Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:Raymond R. CarlsonRPh OwnerRC Outsourcing, LLC102 East Water StreetLowellville,OH44436-1117United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 722877March 20, 2026Dear Mr. Carlson:You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 353b]1on October 7, 2015, and most recently on November 27, 2025. From August 18, 2025 to August 28, 2025, an FDA investigator inspected your facility, RC Outsourcing, LLC located at 102 East Water St., Lowellville, OH 44436. The investigator noted serious deficiencies in your practices for producing drug products, which put patients at risk.FDA issued a Form FDA 483 to your facility on August 28, 2025. We reviewed your September 19, 2025, October 28, 2025, and November 21, 2025, responses to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence on December 31, 2025. FDA also acknowledges that, on September 22, 2025, your firm initiated a voluntary recall of four (4) lots of Bevacizumab 1.75 mg/0.07 mL Syringe, 0.25 mL, within expiry, due to a lack of sterility assurance. Based on this inspection, it appears you produced drugs that violate the FD&C Act.A. Compounded Drug Products under the FD&C ActUnder section 503B(b) of the FD&C Act, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FD&C Act [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FD&C Act [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FD&C Act are met.An outsourcing facility, which is defined in section 503B(d)(4) of the FD&C Act [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that—(i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FD&C Act, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.B. Violations of the FD&C ActAdulterated Drug ProductsThe FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FD&C Act. For example, the investigator observed that:1. You exposed sterile drugs and materials to lower than ISO 5 quality air.Specifically, your handling of container-closure system components for Povidone-Iodine Sterile Ophthalmic Solution may result in contamination. During the repackaging process, dropper bottle caps containing the applicator tips are staged(b)(4)on the surface of your ISO 5 laminar flow hood. This practice exposes critical surfaces—specifically, the interior of the dropper bottle cap and the applicator tip—to the non-sterile surface of the ISO 5 hood. Additionally, this(b)(4)The FDA investigator also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act. The violations include, for example:1. Your firm failed to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).2. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing area (21 CFR 42(c)(10)(iv)).3. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic processes (21 CFR 211.113(b)).4. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).5. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1), 211.84(d)(2)).6. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FD&C Act. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance,Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.Under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FD&C Act [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.Unapproved New Drug ProductsYou do not have any FDA-approved applications on file for the drug products that you repackage, such as Povidone-Iodine 5% Ophthalmic Solution.2Under sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 331(d)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FD&C Act is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FD&C Act.3In addition, you do not have any FDA-approved applications on file for certain other products that you manufacture, such as Bevacizumab 1.75 mg/0.07 mL, 0.25 mL Syringe. Products such as Bevacizumab 1.75 mg/0.07 mL, 0.25 mL Syringe are unapproved new drugs under section 505 of the FD&C Act [21 U.S.C. § 355(a)] and also biological products under section 351 of the Public Health Service Act (PHS Act) [42 U.S.C. § 262]. In order to lawfully market a drug that is also a biological product, a valid biologics license application (BLA) must be in effect under the PHS Act. Your biological products, such as Bevacizumab 1.75 mg/0.07 mL, 0.25 mL Syringe, are not the subject of an approved BLA. The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(d) of the FD&C Act [21 U.S.C. § 331(d)].4Misbranded Drug ProductsYou repackage drug products, such as Povidone-Iodine 5% Ophthalmic Solution, that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses.You manufacture other products, such as Bevacizumab 1.75 mg/0.07 mL, 0.25 mL Syringe, that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use this product safely for their intended uses.Accordingly, the labeling of these products fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FD&C Act.5Additionally, the label of a product you manufacture, Bevacizumab 1.75 mg/0.07 mL, 0.25 mL Syringe, states that the quantity or proportion of bevacizumab is 1.25 mg. However, based on the declared concentration of 25 mg/mL, the accurate quantity or proportion of bevacizumab in your 0.25 mL syringe is 1.75 mg. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Because the labeling of this drug product is false or misleading, it is misbranded under section 502(a) of the FD&C Act.The introduction or delivery for introduction of misbranded drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act. It is also a prohibited act under section 301(k) of the FD&C Act to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.C. Corrective ActionsWe have reviewed your facility’s responses to the Form FDA 483. We acknowledge your recall of the following four (4) lots of Bevacizumab 1.75 mg/0.07 mL Syringe, 0.25 mL, within expiry, due to a lack of sterility assurance. We are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:1. Regarding your firm’s failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic processes:We acknowledge the actions your firm has taken in response to the failure to ensure that components of your container-closure system, used for sterile ophthalmic drug products, are handled in a manner that maintains their sterility. We note your statement that “All Betadine (povidone-iodine) production has been suspended as of 28-AUG-2025 to allow the quality unit to assess and evaluate a potential new container-closure system and the repackaging process.” While we acknowledge that temporarily suspending production of this drug product mitigates immediate risk, you have not submitted documentation describing your Quality Unit's evaluation of any process modification designed to prevent microbiological contamination. Your response did not include a timeframe for completion of this evaluation or a plan outlining the specific steps your firm will take to resolve this deficiency.2. Regarding your firm’s failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity:We acknowledge the actions your firm has taken in response to the failure to employ appropriately validated analytical methods for assay testing of active pharmaceutical ingredients (API) in the following drug products: Lidocaine 23%-Tetracaine 7% ointment (LT), Lidocaine, USP 20%-Tetracaine, USP 6%-Phenylephrine, HCl 2% ointment (LTP), Benzocaine 20%-Lidocaine 6%-Tetracaine 4% ointment (BLT), and Lidocaine HCl 2% Injection. We noted your commitment to suspend all production of drug products using bulk API powder until strength methods are validated for CGMP release testing, and that you continue working with your contract testing laboratory to develop and validate these methods. While temporarily suspending production mitigates immediate risk, we cannot fully evaluate the adequacy of your long-term corrective action plan without additional documentation. Specifically, we require fully executed analytical method validation protocols demonstrating successful method validation, including appropriately defined system suitability criteria.3. Regarding your firm’s failure to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced:We acknowledge the actions your firm has taken in response to the failure to consistently record the lot numbers of sterile,(b)(4)beakers ((b)(4)Sterile Beakers) and sterile(b)(4)in the batch production records for Lidocaine 2% Injection. We note your commitment to verify the accuracy and completeness of batch production records going forward. However, we cannot fully verify the adequacy of your corrective action plan due to the lack of supporting documentation, such as executed batch production records demonstrating implementation of the corrective actions. We recognize that your firm has suspended production of drug products produced from API, including Lidocaine 2% Injection. Given this production suspension, demonstrating full correction of this violation may not be feasible at this time. Therefore, the effectiveness of your corrective actions will be assessed during the next inspection of your firm.Some of your corrective actions appear deficient:4. Regarding your firm’s failure to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed:a. We acknowledge the actions taken by your firm in response to your failure to adequately investigate the sterility failure of bevacizumab, lot # 20250428-488A81, and to extend the investigation to other potentially affected batches of drug product. Your investigation, documented as Nonconformance Report-2 (NCR-2), identified a medical condition (i.e., eczema) experienced by a sterile drug production operator as the likely cause of the contamination. According to the timeline you provided, the operator in question experienced the skin condition for approximately three months (i.e., from 04/21/2025 to 07/21/2025), yet your firm did not evaluate the potential impact on other drug product batches manufactured during this period. Additionally, despite identifying the operator's medical condition as a potential root cause, you allowed the operator to continue performing aseptic operations while wearing a patch, although you failed to provide evidence supporting the effectiveness of this control measure in reducing contamination risk. In addition, while the revised SOP-28 “Out-of-Specification and Out-of-Trend Investigations” (effective 09/12/2025) now requires evaluation of all lots produced within a particular timeframe and/or by the same operator, the procedure fails to consider other variables that may contribute to such deviations or discrepancies (e.g., drug product contamination). A comprehensive investigation should evaluate common elements such as equipment, components, and personnel in an effort to determine both potential root cause(s) and the full scope of the event.b. We acknowledge the actions taken by your firm in response to your failure to investigate numerous instances of microbial recovery from the sleeves of gowns worn by operators who enter the ISO 5 space during sterile drug production. We note that SOP-57 “Testing of Sterile Environment” (effective 07/16/2025), which was current at the time of these microbial excursions, defined the Action Limit for sleeves as “(b)(4)CFUs.” We acknowledge your intent to “change the CFU action limit to(b)(4)for sleeve monitoring” and recognize your voluntary recall of four (4) lots of drug product, each associated with the recovery of 1 CFU from the sleeve of a production operator involved in producing the respective batch.However, your response fails to address significant elements of the violation. Although you acknowledge the failure to investigate an adverse trend in personnel monitoring results, you have not initiated a retrospective investigation into this discrepancy. Consequently, you have not identified a root cause or implemented corrective and preventive actions to prevent recurrence.We further note that SOP-57 “Testing of Sterile Environment” (effective 07/16/2025), which was current when this violation occurred, defined an “Alert Limit” for “ISO 7 (Sleeves)” at “(b)(4)CFUs.” However, your procedures do not define the implications of meeting or exceeding an Alert Limit. Additionally, your firm has not committed to defining what constitutes an adverse “trend” or how it will analyze such data when identified. Finally, the classification of sleeve samples as “ISO 7” is inappropriate because operators' sleeves routinely enter the ISO 5 space during aseptic operations.5. Regarding your firm’s failure to establish an adequate system for monitoring environmental conditions in aseptic processing area:a. We acknowledge the actions your firm has taken in response to the failure to perform adequate viable air monitoring within the ISO 5 laminar flow hood during sterile drug production activities. We note your plan to(b)(4)“to provide a better representative air sample in ISO 5 conditions.” However, you have not fully implemented and documented this corrective action through batch production records and associated environmental monitoring data. Additionally, the qualification of any such equipment should include airflow visualization studies (i.e., “smoke studies”) to demonstrate that the equipment does not adversely affect laminar airflow within the ISO 5 space and, therefore, does not compromise drug product protection.b. We acknowledge the actions your firm has taken in response to the failure to ensure that settle plates used for passive air monitoring of the ISO 5 laminar flow hood during sterile drug production are appropriately positioned to generate data representative of the ISO 5 environment during aseptic operations. We acknowledge your plan to replace(b)(4)plates with(b)(4)plates, as(b)(4)plates are not appropriate for passive air (i.e., “settle plate”) monitoring. We further note the revisions to section 5.6.2 of SOP-57 “Testing of Sterile Environment” (effective 10/15/2025), which now states, in part, that settle plates should be “placed within the ISO 5 space near the area of highest activity or critical manipulations... without obstructing airflow or work...” However, while your response indicates that plates will now be located in closer proximity to critical operations, it fails to describe the process by which these locations are determined or whether airflow visualization studies will be conducted to verify that the plates do not adversely affect airflow within the ISO 5 space.c. We acknowledge the actions your firm has taken in response to operators' failure to properly perform personnel sampling and monitoring (i.e., gown sleeve) as part of your environmental monitoring program. We note your plans to retrain personnel on the proper technique. However, your response failed to provide evidence that personnel have been adequately retrained and are qualified to conduct personnel sampling (i.e., gown sleeve) appropriately and consistently.6. Regarding your firm’s failure to establish the reliability of your component supplier’s test analyses (i.e., Certificates of Analysis) at appropriate intervals, as well as your failure to conduct at least one test to verify the identity of each shipment of every lot of components:We acknowledge the actions your firm has taken in response to the failure to conduct at least one identity test on each shipment of every lot of components, including APIs. Specifically, we note the implementation of SOP-94 “Active Pharmaceutical Ingredient Identification Testing” (Version 3.0, Effective September 12, 2025). However, your procedure contains a significant gap. Section 5.1.3 states, “If a(b)(4)lot number of an API is received, it will be held in quarantine until sampling can be obtained for identity testing.” This language indicates that your procedure would permit subsequent shipments of a previously received lot to be released to production without identity testing. This approach is inadequate. The regulatory requirement is that each shipment of each lot must be subject to at least one identity test, regardless of whether that lot number has been received previously. Lastly, your response does not include a corrective action plan to address the requirement to establish the reliability of your supplier's analyses at appropriate intervals, such as(b)(4)for APIs.In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products.Seesection 501 of the FD&C Act. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See21 CFR 210.1(b), 21 CFR 200.10(b).]FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.D. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.All correspondence should refer to the Warning Letter Number above (#722877) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research_______________________1See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).2The specific products repackaged by your firm are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their labeled uses.3Drugs that are repackaged are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act. For additional information, you may wish to review FDA’s 2017 guidance document, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.” More specifically, the guidance sets forth conditions under which FDA does not intend to take action against drug products repackaged by pharmacies and outsourcing facilities for certain violations of the FD&C Act. Such conditions include, but are not limited to, the label on the immediate container (primary packaging, e.g., the syringe) of repackaged products including the statement “Not for resale.”4Biological products subject to licensure under section 351 of the PHS Act are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act. For additional information, you may wish to review FDA’s 2018 guidance document, “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.” More specifically, the guidance sets forth conditions under which FDA does not intend to take action for certain violations of the FD&C Act when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. Such conditions include, but are not limited to: (1) the label on the immediate container (primary packaging, e.g., the syringe) of mixed, diluted, or repackaged biological products including the dosage form; and (2) the mixed, diluted, or repackaged biological products are included on a report submitted to FDA each June and December identifying the drug products made by the outsourcing facility during the previous 6-month period.5Your repackaged and manufactured drug products are not exempted from the requirements of section 502(f)(1) of the FD&C Act by regulations issued by the FDA (see, e.g., 21 CFR 201.115).

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-62Product:DrugsRecipient:Dr. Robin C. CummingDirector, Radiopharmaceutical FacilityUCSF Radiopharmaceutical Facility185 Berry St. Ste. 350San Francisco,CA94107-9107United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-62April 13, 2026Dear Dr. Cumming:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, UCSF Radiopharmaceutical Facility, FEI 3005947301, at 185 Berry St. Ste. 350, San Francisco, from July 21 to 24, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for(b)(4)drugs. See Title 21 Code of Federal Regulations (CFR), part(b)(4)(21 CFR part(b)(4)).Because your methods, facilities, or controls for manufacturing, processing, packaging, or holding do not conform to CGMP, your(b)(4)drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your August 14, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to conduct adequate investigations and take appropriate corrective action when a failure of a production batch or any component of the batch failed to meet any of its specifications. (21 CFR (b)(4)).You manufacture(b)(4)drug products for(b)(4)administration. Your investigations into multiple failing sterility test results were inadequate. From 2022 to 2023, you initiated multiple investigations into sterility test failures for batches of(b)(4)injection and concluded that the probable root cause was contamination by the operator during sampling of the finished product vial. However, your investigations did not adequately support this root cause.For example, you opened a sterility failure investigation on April 3, 2023, after your analyst reported turbidity in the(b)(4)tube during incubation of your sterility sample for a batch of(b)(4)for injection. The recovered microorganism was identified as Bacillus species, a gram-positive spore-forming bacterium. Although no conclusive laboratory testing errors were found, your investigation postulated that the batch of(b)(4)was contaminated with the bacteria during sterility testing. You invalidated the sterility test result based on your flawed assumption that the organism also should have grown in the(b)(4)tube.Your firm failed to thoroughly evaluate whether this and other batch sterility test failures were caused by deficient aseptic manufacturing practices. Notably, your facility has experienced multiple recoveries of spore-forming organisms in sterility samples and production environments.You also investigated deviations from sterility test procedures in which your analyst discarded sterility samples for at least two(b)(4)batches on(b)(4)of incubation instead of day 14 as specified in USP . Your investigation stated that “it is highly unlikely that bacterial growths would occur on the 14th day of incubation. . . it is more likely that growth would appear before(b)(4)of testing.” However, your firm failed to note that slow growing or injured microorganisms may become detectable at the end of the incubation period.In your response, you indicate that the sterility failures were false positives and that root causes were described in reports for each incident. You also state that you updated your sample labeling and identification procedures to prevent discarding of sterility samples before the required incubation period.Your response is inadequate because there remains a lack of compelling evidence that the sterility failures were attributable to laboratory contamination. Your belief that(b)(4)media must both exhibit growth and if they do not, the test should be considered a false positive, fails to recognize that each medium possesses unique sensitivities, limitations, and growth capabilities. It is not appropriate to require growth in both media to establish a positive sterility failure for a sterile drug product batch.Furthermore, you did not sufficiently detail improvements to ensure that any future sterility positive is investigated properly and includes a comprehensive evaluation of potential manufacturing root causes. Your response also lacks adequate provisions for thoroughly reviewing your sterility test method to minimize potential for false positives.(b)(4)drug products have short expiry periods. Consequently,(b)(4)drug products are released and administered before the results of batch specific sterility testing and environmental monitoring (EM) are known. A robust ongoing EM program is essential to detect and respond to potential product contamination hazards in your manufacturing environment in a timely manner. Loss of environmental control in an aseptic manufacturing facility can ultimately pose a serious hazard to patients.In response to this letter, provide the following:A comprehensive assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-limit (OOL) and out-of-specification (OOS) results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, corrective action and preventive action (CAPA) effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.A retrospective, independent review of all invalidated sterility test results for U.S. products for the last three years from the initial date of inspection and a report summarizing the findings of the analysis, including the following for each sterility test:o Determine whether the scientific justification and evidence relating to the invalidated sterility test result conclusively or inconclusively demonstrates causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o For all sterility test results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.o Also, the independent, third-party review and CAPA plan should identify significant improvements to your sterility testing method that will better ensure minimization of false positives.2. Your firm failed to follow written quality assurance procedures. (21 CFR (b)(4)).You lacked investigations or failed to ensure their timely completion.Your quality unit (QU) did not investigate adverse EM trends in your production areas as required by your standard operating procedure (SOP), SOP Q043 “Laminar Flow Hood Environmental Monitoring.” Specifically, in 2025, multiple EM results fell outside your action limit, but you failed to launch investigations to evaluate the adverse trends.Additionally, your procedure required investigations to be completed within(b)(4). However, our review found systemic failures to meet this timeframe. Numerous investigations remained open for more than a year. For example, two investigations remained open for over 1000 days.In your response, you acknowledge that you failed to follow your procedures for conducting environmental trending investigations. You state that you will perform retrospective investigations, create a new procedure for sterility failures and OOL investigations, and hire a Document Control Manager to oversee quality-related activities.Your response is inadequate because it fails to propose a comprehensive CAPA plan to address systemic deficiencies in your investigation program. Furthermore, it lacks an analysis of the quality assurance oversight failures that allowed these deficiencies to occur and persist.In response to this letter, provide the following:All EM data and personnel monitoring data from June 2023 to present (preferably in a spreadsheet tabular format). Include pertinent details such as sample location, date and time of collection, and colony forming unit (CFU) counts. For each recovery, describe the microbial differentiation performed by the laboratory (gram stain result, color, colony morphology description, genus or species-level identification).Your revised EM SOP detailing ISO 5(b)(4)monitoring during production and requiring identification of all isolates recovered during environmental and personnel monitoring. In addition to your current action limits, confirm that you have established an appropriate limit with associated procedures that ensure evaluation and investigation of such recoveries.A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productso Also describe how top management supports quality assurance and reliable operations, including, but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control3. Procedures to ensure that all equipment is clean, suitable for its intended purposes, properly installed, maintained, and capable of repeatedly producing valid results, are not adequately followed. (21 CFR (b)(4)).Your procedures lack sufficient details to ensure that you adequately control and monitor your equipment for aseptic conditions. During our inspection, investigators observed your technician performing contact plating of the ISO 7 area of the(b)(4)immediately after disinfection of surfaces with(b)(4), a practice which is likely to inhibit microbial growth on the sampling media and produce false negative results. Additionally, you lacked EM of the ISO 5 area of the(b)(4)where aseptic manipulations of sterile(b)(4)drug products occur(b)(4). An effective environmental monitoring program, with samples that appropriately represent production conditions, is essential for detecting microbial contamination in critical areas and triggering prompt actions to maintain a state of control.In your response, you explain that contact plating is performed in the ISO 7 area to establish cleaning efficacy prior to production, and that you use air settle plates for EM in the ISO 7 area during production, as there are no opportunities to sample inside the(b)(4)after(b)(4). You commit to updating your disinfection procedures to include allowing disinfectants to fully dry before contact plating. You also commit to performing EM of the ISO 5 area where quality control and sterility samples are withdrawn from the finished product vial within the(b)(4).Your response is inadequate. Although spore-forming microbes were identified in several instances, you did not provide evidence that you comprehensively evaluated efficacy of disinfection procedures (e.g., sufficiency of methods, frequency of use, before handling of material transfers), in response to these events. Furthermore, you did not provide an assessment of how the lack of sufficient EM data within the(b)(4)ISO 5 and ISO 7 areas impacts the ability to meaningfully identify environmental trends as part of your root cause determination of sterility failures. Vigilant and responsive EM programs should be designed to provide meaningful information on the state of control of your aseptic processing environment and ancillary classified areas.In response to this letter, provide the following:Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.An independent assessment of your EM program including, but not limited to, establishing appropriate limits, sampling locations and frequencies (including in ISO 5 environment), investigating deviations, and trend analysis, and a comprehensive CAPA plan.A CAPA plan, based on the retrospective assessment of your cleaning and disinfection program, that includes appropriate remediations to your cleaning and disinfection processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning and disinfection. Describe improvements to your cleaning and disinfection program, including enhancements to cleaning effectiveness, improved ongoing verification of proper cleaning and disinfection execution for all products and equipment, and all other needed remediations.Guidance on (b)(4) DrugsSee FDA’s guidance document(b)(4)to help you meet the CGMP requirements when manufacturing(b)(4)drugs, at(b)(4). This guidance document also references FDA’s guidance documentSterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practicewith additional concepts and expectations that may apply to(b)(4)drug manufacturing, at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Field Alert ReportingYour firm failed to submit Field Alert Reports to FDA in compliance with 21 C.F.R. 314.81(b)(1)(ii), as required by section 505(k) of the FD&C Act [21 U.S.C. 355(k)] upon discovery of a product quality defect. An applicant is required to submit, within three working days of receipt, information concerning any bacteriological contamination or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of drug product to meet the specifications established for it in the application.The intent of the 21 CFR 314.81(b)(1) regulation is to establish an early warning system so that significant problems are brought to the Agency’s attention by applicant holders to prevent potential safety hazards from drug products already in distribution.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days.1Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3005947301 and ATTN: Christopher Keating.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research________________1Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:James KrogmanPresident and CEOApollo Care, LLC3801 Mojave Court, Suite 101Columbia,MO65202-4042United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 715955February 2, 2026Dear Mr. Krogman:You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]1on September 14, 2017, and most recently on December 24, 2025. From March 10, 2025, to March 27, 2025, an FDA investigator inspected your facility, Apollo Care, LLC, located at 3801 Mojave Court, Suite 101, Columbia, MO 65202. During the inspection, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.FDA issued a Form FDA 483 to your facility on March 27, 2025. FDA acknowledges that on April 15, 2025, your firm initiated a voluntary recall of Lot AC-016878 of Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), within expiry, due to lack of sterility assurance. FDA also acknowledges receipt of your facility’s responses, dated April 17, 2025, June 10, 2025, and September 8, 2025. Based on this inspection, it appears you produced drugs that violate the FDCA.A. Compounded Drug Products under the FDCAUnder section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.B. Violations of the FDCAAdulterated Drug ProductsThe FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed:1. You used sanitizing and sporicidal agents without providing adequate segregation in preventing contamination of in-process bulk drug solution. Specifically, your operator repeatedly sprayed a microfiber mop head with cleaning agents near the beaker containing non-sterile bulk drug solution that was loosely covered with aluminum foil in the ISO(b)(4)classified Hallway/Anteroom(b)(4)during area cleaning.2. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO(b)(4)aseptic processing area. Instead, your firm approved and distributed drug products that were produced with 1 CFU recoveries found on ISO(b)(4)operator gowning gloves or sleeves.3. Your firm had foreign matter in the production area. Specifically, white fiber-like particles and debris were observed on the floor of the ISO(b)(4)Lab, where ISO(b)(4)laminar air flow hoods (LAFHs) are located, and the ISO(b)(4)Hallway/Anteroom(b)(4)following area cleaning that included equipment, ceilings, walls, and floors.4. Your firm had production areas or equipment that are difficult to clean or contain porous, particle-generating, or visibly dirty (e.g., rusty) equipment or surfaces (e.g., shelving, floors, walls, doors, ceilings). Specifically, wall panels overlaid on top of your ISO(b)(4)Hallway/Anteroom(b)(4)walls are not smooth. The textured surface is difficult to clean and may harbor contamination and generate particles when other materials come into contact with it.The FDA investigator also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:1. You failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).2. You failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).3. Your firm’s aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance,Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.It is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.C. Corrective ActionsWe have reviewed your facility’s responses to the Form FDA 483. We acknowledge your voluntary recall of Lot AC-016878 of Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), within expiry, due to lack of sterility assurance on April 15, 2025. We also acknowledge that you have contracted with third party consultants.Some of your corrective actions appear adequate. However, we are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:1. Regarding your smoke studies, we acknowledge you have initiated a revision of SOP CQI025Air Flow Pattern Visualizationand intended to conduct “formal static and dynamic smoke studies,” as stated in your June 10, 2025, response. Your September 8, 2025, response provided the protocol and report in Attachment 2 for the May 30, 2025, static smoke studies of the(b)(4)hoods, as part of CAPA C-25-013. However, the protocol and report did not specify what production equipment was included during testing. Without accompanying videos, we lack evidence to evaluate or verify whether you have resolved the issue of turbulence around production equipment such as the repeater pump. This turbulence will persist given that the repeater pump represents a substantial piece of equipment within a(b)(4)laminar flow hood. The report only provided a general statement indicating that “[t]hese static conditions were tested using an LFH [laminar flow hood] with all production materials inside but without any operational tasks being conducted.” Given that these hoods are located in(b)(4)separate rooms and serve distinct functions, each would require different equipment/materials that should have been specifically documented and evaluated.2. Regarding the bulk drug solution exposed to(b)(4)during(b)(4)cycles, we acknowledge you will no longer store the bulk solution in(b)(4)Lab(b)(4)during any(b)(4)cycle until you “can demonstrate there is no opportunity for(b)(4)ingress for the exposure concentration and hold duration.” You also engaged(b)(4), a(b)(4)equipment manufacturer, to assist in developing a(b)(4)penetration study protocol specific to the(b)(4)bag material and provided the results of the(b)(4)penetration study in your September 8, 2025, response. You stated this study utilized the(b)(4)exposure time, the(b)(4)exposure, and the(b)(4)bag to demonstrate compatibility. However, this study appeared to test empty bags and bags filled with(b)(4). It is not clear why you did not test bags filled with any bulk drug product, such as bulk Vancomycin solution, or whether you have conducted other container closure compatibility studies as part of the process validation of the drug products. Therefore, we lack data to fully evaluate whether the storage bags filled with your bulk drug solution are suitable for their intended use, including exposure to the(b)(4)used in your facility.Some of your corrective actions appear deficient:1. Regarding your firm’s cleaning of the ISO(b)(4)Hallway/Anteroom(b)(4)while non-sterile in-process bulk drug solution was stored there, your firm lacked assurance that the non-sterile in-process bulk drug solutions exposed to cleaning agents during this cleaning process do not alter the quality and purity of sterile compounded finished drug product produced from the exposed bulk drug solution.We acknowledge you will no longer store the bulk drug solution in the area while the cleaning or(b)(4)cycles are ongoing, and that SOP PRC004(b)(4)Processrequires disinfection and cleaning of any supplies that must be transferred from an unclassified space to an ISO environment. However, the effectiveness of using a(b)(4)lid to replace foil covering on the bulk drug solution beaker has not been demonstrated or validated through appropriate methods such as media fills. Additionally, your SOP and related batch record forms do not require or specify how to clean and/or disinfect the large beaker, including the new(b)(4)lid, containing non-sterile bulk drug solution formulated in ISO(b)(4)Storage/Anteroom(b)(4)when transferring from one area to another, particularly from Anteroom(b)(4)(ISO(b)(4)) to(b)(4)Lab (ISO(b)(4)).2. Regarding your firm’s use of the Hallway/Anteroom(b)(4)as both ISO(b)(4)and ISO(b)(4)space depending on whether you are conducting non-sterile or sterile activities, your response is inadequate because you provided contradictory and incomplete information on how the ISO(b)(4)Lab will be accessed. You continue using the Hallway/Anteroom(b)(4)as an entry to reach both non-sterile and sterile activities. In your June 10, 2025, follow-up response, you reiterated that “this hallway is used as an entry to both an ISO(b)(4)and an ISO(b)(4)space” and acknowledged the risk of using Hallway/Anteroom(b)(4)for an entry to both ISO(b)(4)and ISO(b)(4)rooms.The following responses appear to be contradictory:In your April 17, 2025, response to Observation 2A, you stated, “Per Change Control 25-CM-016, the non-sterile bulk drug solution is now moved from the ISO(b)(4)Anteroom into the ISO(b)(4)room after the technician completes full sterile gowning with sterile gloves and completes a thorough wipe down of the beaker with(b)(4). The ISO(b)(4)Anteroom is then subjected to a full cleaning.”In your June 10, 2025, response to Observation 2B, you stated, “Apollo Care requires that Anteroom(b)(4), or what was referred to as the hallway, to undergo a full clean prior to gowning and entry into the ISO(b)(4)environment. This requirement is in place when ISO(b)(4)activities have occurred immediately prior to the need for ISO(b)(4)entry.”In your response to Observation 2A, non-sterile bulk solution is moved into the ISO(b)(4)room before a full clean of Hallway/Anteroom(b)(4), while in your response to Observation 2B, you state that ISO(b)(4)access first requires sterile garbing and full cleaning of Hallway/Anteroom(b)(4).3. Regarding the EM (environmental monitoring) Alert and Action limits for personnel who access the ISO(b)(4)environment, we acknowledge you have defined(b)(4)and(b)(4)support compounding personnel in SOP EMP001(b)(4)Support Compounding Personnel Job Descriptionand SOP EMP002(b)(4)Support Compounding Personnel Job Description. You also updated SOP CQI003Clean Room Monitoringto define respective Alert and Action Limits for(b)(4)and(b)(4)support compounding personnel and require labeling “(b)(4)” for(b)(4)support compounding, and “(b)(4)” for(b)(4)support compounding on the Personnel Monitoring plates.However, you have not designated fields to document(b)(4)Support Compounding Personnel in related forms used in batch records, such as EM/PM form F002. For example, in the newest version of form F002, you still list “(b)(4)” and “(b)(4)” under each category of Direct Compounding Personnel and(b)(4)Support Compounding Personnel Contact Plates. Furthermore, the scope of the(b)(4)’s role during compounding operations has not been specified in batch record instructions, or in any updated written procedure.IMAGE (b)(4)4. Regarding white fiber-like particles and debris observed on the floor of the ISO(b)(4)Lab and the ISO(b)(4)Hallway/Anteroom(b)(4)following area cleaning, we acknowledge you rejected and destroyed the three affected lots. However, you have not provided any preventive actions regarding particles observed in the anteroom and in the cleanroom space where ISO(b)(4)LAFH used for production are located. In your June 10, 2025 response, the specification sheet from(b)(4). (refer to pages 95-96 of the Response Attachment 3) appeared to be a specification sheet for(b)(4)Mop, which is a different product line, with part numbers such as(b)(4), none of which appeared to match the mops being used at your firm.5. Regarding documentation of incomplete(b)(4)cycles, your SOP PRC002Facility Cleaning Procedureonly mandates documentation of “all executed facility cleanings.” However, the SOP fails to address the documentation requirements for incomplete(b)(4)cycles within individual rooms or incomplete “full clean” of the cleanroom suite (all(b)(4)rooms). CGMP regulations require comprehensive documentation of all CGMP activities, including those that are incomplete or terminated early. The SOP should be revised to include:Documentation requirements for all(b)(4)cycle attempts, whether completed or incomplete; andExplanation for partial or terminated cycles.6. Regarding the textured panels in your cleanroom suite, the manufacturer’s Technical Data sheet indicates the panels with textured or smooth surface have fire, mold and mildew resistance. However, there is no statement in the Technical Data sheet supporting the panel’s suitability for cleanroom applications, especially for pharmaceutical manufacturing facilities producing products intended to be sterile. Your response is inadequate because you have not evaluated the risk associated with using walls with textured surface in the cleanroom suite, nor have you developed a strategy to mitigate this risk. The photograph below depicts a section of the reconstructed area and wall in the ISO(b)(4)Hallway/Anteroom(b)(4)after the sink removal. The image shows difficult to clean areas such as textured wall surface and the gap in the molding.IMAGE (b)(4)In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b).]FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.D. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.All correspondence should refer to the Warning Letter Number above (# 715955) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research______________________1See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-26-65Product:DrugsRecipient:Mr. Arthur LeongDirector, QANew Life Pharma LLC265 Livingston StreetNorthvale,NJ07647-1901United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-65April 14, 2026Dear Mr. Leong:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, New Life Pharma LLC, 3012113519, at 265 Livingston Street, Northvale, from February 3 to February 13, 2026. Based on the inspection and a review of the evidence collected, we identified serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).Your “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). These products are misbranded drugs under section 502(o) of the FD&C Act, 21 U.S.C. 352(o) because you did not properly register you firm or list your drugs with FDA.In addition, your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).Finally, during the inspection our FDA investigators documented that your firm delayed, denied, limited, and/or refused to permit an FDA inspection. Under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has delayed, denied, limited, and/or refused to permit inspection.Introducing or delivering these drugs for introduction into interstate commerce violates sections 301(a), 301(d), 301(p), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), 331(p), and 355(a).Unapproved New Drug ViolationsYour “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” are “drugs” under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Multiple factors demonstrate that these products are intended for use as drugs.For example, your registration as a drug manufacturer and listing of a semaglutide injectable drug in FDA’s drug registration and listing system provides evidence of your intent for these products to be used as drugs. (see 21 CFR 207.77(c)).Additional evidence that your products are intended to be used as drugs (see 21 CFR 201.128) includes their composition, consisting of semaglutide or tirzepatide active pharmaceutical ingredients, which are well-known as the active ingredients in drugs approved for indications related to weight loss and management of type 2 diabetes; their design as lyophilized powder in sterile glass multi-dose vials with rubber stoppers requiring reconstitution and parenteral injection; and the circumstances of their distribution, including shipment to weight loss clinics (“med spas”) and cosmetic surgery medical practices. In at least some instances, you shipped the drug with bacteriostatic water purchased online, providing the means to prepare an injectable drug for human administration. In addition, your labels for your products include a National Drug Code (NDC), as well as the term “Rx-only,” and “Sterile Multi-Dose Vial; Refrigerate after reconstitution,” indicating use as a prescription drug.Taken together, these factors collectively demonstrate your objective intent for these products to be used as drugs. Thus, your “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” are “drugs” as defined in section 201(g)(1) of the FD&C Act.These products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for their labeled uses. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Based on a review of Agency records, no FDA-approved applications are in effect for your “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial.” Accordingly, these products are unapproved new drugs, and their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Misbranded Drug ViolationsFailure to properly register and list i. Misrepresentation of manufacturing operations in your FDA firm registrationYour firm failed to meet its registration and listing obligations under section 510 of the FD&C Act. Section 510 of the FD&C Act, 21 U.S.C. 360 requires, among other things, owners or operators of establishments engaged in the manufacture of drugs to register their establishments with FDA. Registrants must provide accurate information regarding the types of operations performed at each establishment (see 21 CFR 207.25(f)). A review of FDA’s drug registration database shows that New Life Pharma LLC registered as “Contract manufacturing for human over-the-counter drug products produced under a monograph.” However, our inspection revealed that your firm does not manufacture any OTC monograph drugs. Instead, your firm manufactures and distributes unapproved prescription drugs, including “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial.” Your firm's registration information misrepresents the type of drugs manufactured at your establishment and the nature of your manufacturing operations. ii. Failure to obtain a labeler code to properly list your drugs with FDAYour firm has also failed to fulfill its listing obligations under section 510(j) of the FD&C Act, 21 U.S.C. 360(j). New Life Pharma does not have any labeler codes assigned and has not listed any drugs with FDA, despite manufacturing drugs products for commercial distribution. Under 21 CFR 207.41, each registrant must list each drug that it manufactures for commercial distribution. Your firm manufactures various drugs, including finished drugs mentioned in this warning letter, but has not obtained a labeler code or listed any products under your labeler code.The failure to register in accordance with section 510 of the FD&C Act, 21 U.S.C. 360, and the failure to list your drugs in accordance with section 510(j), 21 U.S.C. 360(j), is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, your drugs are misbranded drugs under section 502(o) of the FD&C Act, 21 U.S.C. 352(o), because they were manufactured at an establishment not duly registered under section 510 and were not properly listed with FDA under section 510(j).Accordingly, “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” products are misbranded drugs, and their distribution into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).CGMP ViolationsDuring our inspection, our investigators observed specific violations including, but not limited to, the below. We reviewed your March 6, 2026, response to our Form FDA 483 in detail.1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).Your firm manufactured multiple GLP-1 finished drug products such as sterile, multi-dose vials of semaglutide and tirzepatide, without appropriate procedures to prevent microbiological contamination of your drug products, purporting to be sterile.Your firm did not adequately validate the conditions under which you manufactured drug products intended to be sterile. For example, you did not perform aseptic processing simulations (media fills), airflow visualization (smoke) studies, cleaning validation, or establish a routine environmental monitoring program. In addition, you manufactured these drug products under purported ISO 8 conditions without adequate supporting microbiological and particulate data. This did not meet critical area (ISO 5) standards for aseptic operations.These deficiencies demonstrate that your firm lacked the fundamental controls necessary to ensure the sterility of your drug products. The requirements in 21 CFR 211.113(b) for sterile drugs are necessary to ensure sterility and safety of drugs administered to patients. Your failure to implement these requirements placed patients at serious risk of receiving non-sterile products, which could result in severe infections or other life-threatening complications.2. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your quality unit failed to ensure appropriate CGMP procedures and processes for the manufacturing of semaglutide and tirzepatide sterile multi-dose vials were established and followed. For example:Failure to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).Failure to conduct appropriate laboratory testing to determine whether each batch of drug product purporting to be sterile and pyrogen-free conforms to such requirements (21 CFR 211.167(a)).Failure to establish and follow written procedures for cleaning and maintenance of equipment (211.67(b)).Failure to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).These failures demonstrate that your quality control unit did not fulfill its fundamental responsibility to ensure that your manufacturing operations comply with CGMP requirements and that your drug products meet appropriate quality standards. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsto ensure drug safety at https://www.fda.gov/media/71023/download.Limiting the InspectionDuring the inspection, your firm denied FDA investigators access to two areas within the manufacturing suite labeled “Area Not In Use” stating the investigators did not have authority to enter these areas. You confirmed to the investigators that you were refusing access.This causes your drugs to be adulterated under section 501(j) of the FD&C Act, 21 U.S.C. 351(j). Under this provision, drugs are deemed adulterated if they have been manufactured, processed, packed, or held in an establishment where the owner, operator, or agent in charge has delayed, denied, limited, or refused an FDA inspection.FDA’s inspection authority under section 704(a) of the FD&C Act, 21 U.S.C. 374(a), extends to all areas of drug manufacturing facilities, including areas designated as “not in use.” Your designation of certain areas does not limit FDA’s statutory inspection authority. See FDA’s guidance documentCircumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspectionat https://www.fda.gov/media/86328/download.Inadequate ResponseWe reviewed your March 6, 2026, response to our Form FDA 483 in detail. Your response is inadequate because you fail to provide adequate evidence of corrective actions taken to bring your operations into compliance with CGMP or confidence that you can manufacture sterile drugs. Drug manufacturers labeling their product as sterile must recognize the serious public health implications of distributing a non-sterile product as it poses a significant health risk to patients.Drug Production CeasedOn February 20, 2026, you committed to cease production of drug products at your facility. However, in later correspondence dated March 6, 2026, you indicated that production has been paused until appropriate media fill validation studies are completed, indicating that you intend to resume production after addressing the violations associated with sterile drug manufacturing.Considering all the drugs you manufactured are not approved by the agency and your systems for manufacturing sterile drugs are wholly lacking, you should not restart drug manufacturing at this facility. In response to this letter confirm that you will not manufacture drugs in the future.Drug RecallOn February 19, 2026, FDA held a teleconference with you recommending you consider removing any batches of the GLP-1 drug products currently in distribution from the U.S. market.On February 25, 2026, you issued a voluntary recall of semaglutide and tirzepatide sterile multi-dose vials due to lack of assurance of sterility. The recalls were posted to the FDA’s Enforcement Report website at:https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=218926https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219020https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219021ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.This letter notifies you of our findings and provides you an opportunity to address them. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012113519 and ATTN: Maria Pavco.Sincerely,/S/Jill P. Furman, JDDirectorOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA EMAIL WITH READ RECEIPTProduct:DrugsRecipient:Mr. Haisen YangGeneral ManagerXiamen Kang Zhongyuan Biotechnology Co., Ltd.No. 2018-2, Jietou RoadXiang'an QuXiamen ShiFujian Sheng,361101ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-56March 23, 2026Dear Mr. Yang:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Xiamen Kang Zhongyuan Biotechnology Co., Ltd., FEI 3027976266, at No. 2018-2, Jietou Road, Xiang’an District, Xiamen, Fujian 361101, China, from August 12 to 15, 2025.Because your drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, your drug products are adulterated within the meaning of section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 351(a)(2)(A).We reviewed your September 8, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following:Insanitary ConditionsYou do not have adequate controls in place to maintain a suitable production environment and to prevent contamination of drug products manufactured at your facility. During the inspection, FDA investigators observed areas of your facility to be in a state of disrepair, poorly cleaned, and poorly maintained, as evidenced by:Grime and discolored lubricant observed on manufacturing equipment, including a(b)(4)machine used to(b)(4)drug products. Your firm stated that some portion of drug products is routinely discarded due to lubricant contamination during the use of this equipment.Standing water observed on the floor of the manufacturing area, and standing water inside equipment marked as clean.A visibly dirty tube attached to a(b)(4)in your manufacturing area, used to transfer(b)(4), which is a component in your manufacturing.Unknown liquid droplets on surfaces directly above manufacturing equipment.Flies in the manufacturing area.A live cockroach in the secondary packaging area.Apparent mold on the air-conditioning vents in the storage area for bulk drug products and components.In your response, you provided information regarding the corrective actions you completed, or plan to complete, to address the observations noted during the inspection. For example, you stated that you performed an immediate cleaning of the(b)(4)machine, and that you plan to implement a cleaning and validation plan.Your response is inadequate because you failed to conduct a retrospective review and assessment of the risks to product quality, including all potential contamination risks.In response to this letter, provide the following:Your corrective action and preventive action plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection and effective remediation of equipment/facilities issues, adherence to appropriate preventive maintenance schedules, and improved systems for ongoing management review.Detailed procedures demonstrating that your firm can maintain buildings free from pests and that your buildings can remain clean and sanitary.Documentation that supports your corrective actions, such as work orders, room qualification, photos of any repairs your firm has made to correct the violation, and systemic plans to ensure that the manufacturing areas remain adequately designed, controlled, and maintained.Access to information during inspection, and delaying, denying, and limiting the inspectionDuring the inspection, your firm also made misleading or deceptive statements and may have delayed the investigators’ access to accurate and truthful information. For example:Your Chief Quality Officer admitted to providing false documents related to the testing of your finished drug product.Your firm provided false manufacturing records related to ingredient quality testing. Our investigators requested a copy of a logbook on August 13, 2025, that appeared to contain missing data (i.e., the logbook had blank spaces where entries should have been recorded). After repeated inquiries, you provided the manufacturing logbook to our investigators on August 15, 2025, with information recorded that had not been present on August 13, 2025, the date of our original request. Your firm later acknowledged that the associated laboratory records were “missing.”When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated under section 501(j) of the FD&C Act. See FDA’s guidance document Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection at https://www.fda.gov/media/86328/download. See also FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.In your response, you committed to ensuring that proper testing and recordkeeping protocols are in place before the release of batches. Your response is inadequate because you did not conduct a comprehensive evaluation of other records in which data may have been misrepresented or manipulated by your employees.We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies in data records and reporting, including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity, and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global corrective action and preventive action plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm, including microbiological and analytical data, manufacturing records, and all data submitted to FDA.Drug RecallOn March 4, 2026, FDA held a teleconference with you recommending you consider removing batches of mentholated cough drops currently in distribution from the U.S. market. You agreed to initiate a recall of certain lots after the discussion.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on March 20, 2026.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Xiamen Kang Zhongyuan Biotechnology Co., Ltd., into the United States under section 801 of the FD&C Act, 21 U.S.C. 381. Articles under this authority that appear to be adulterated or misbranded are subject to detention or refusal of admission.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3027976266 and ATTN: Maria Pavco.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Doug HatchOwnerThrive Health and Wellness, LLC dba Thrive Health Solutions88 Inverness Circle East, Ste A-204Englewood,CO80112-5521United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 714891February 9, 2026Dear Mr. Hatch:From March 25, 2025, to April 3, 2025, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Thrive Health and Wellness, LLC dba Thrive Health Solutions, located at 88 Inverness Circle E Ste A-204, Englewood, CO 80112. During the inspection, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.FDA issued a Form FDA 483 to your firm on April 3, 2025. FDA acknowledges receipt of your facility’s response, dated April 22, 2025. FDA further acknowledges that as of April 21, 2025, your firm ceased repackaging of sterile drug products not intended for immediate use. FDA also acknowledges that on May 21, 2025, your firm initiated a voluntary recall of all repackaged sterile drug products dispensed between January 2, 2025, to April 18, 2025, due to a lack of sterility assurance. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).A. Compounded Drug Products Under the FDCASection 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].1B. Violations of the FDCAAdulterated Drug ProductsThe FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed that:1. Your personnel were observed conducting aseptic operations outside of a certified ISO 5 area. More specifically, your personnel filled sterile drug products into syringes on a benchtop table located in an unclassified room that shared the workspace with a blood sample centrifuge. These drug products were not intended for immediate administration to patients but were distributed for future administration outside your facility.2. Your personnel performing sterile operations have never performed media fills. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.3. Your aseptic processing and surrounding areas had difficult to clean equipment and surfaces. For example, your entire facility flooring was covered with carpet.4. Your personnel engaged in aseptic processing while wearing non-sterile gloves and with exposed hair and skin.5. Your firm failed to use a sporicidal agent as part of your disinfection program for the aseptic processing area and used non-sterile wipes to clean within the area where drug products were filled into syringes.Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.Unapproved New Drug ProductsYou do not have any FDA-approved applications on file for the drug products that you repackage, such as NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections 10mg/20mg/mL.2These products are unapproved new drugs under sections 505(a) and 301(d) of the FDCA [21 U.S.C. § 331(d)]. A new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application is prohibited under section 301(d) of the FDCA [21 U.S.C. § 331(d)].3Misbranded Drug ProductsThe drug products you repackage, such as NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections 10mg/20mg/mL, are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses.4Accordingly, these drug products are misbranded under section 502(f)(1) of the FDCA. The introduction or delivery for introduction of misbranded drugs into interstate commerce is prohibited under section 301(a) of the FDCA. It is also a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.C. Corrective ActionsWe have reviewed your facility’s response to the Form FDA 483. We acknowledge that as of April 21, 2025, your firm ceased repackaging of sterile drug products not intended for immediate use. We also acknowledge that on May 21, 2025, your firm initiated a voluntary recall of all repackaged sterile drug products dispensed between January 2, 2025, to April 18, 2025, due to a lack of sterility assurance.D. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.If you decide to resume operations to produce sterile drug products not intended for immediate use, you should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations, or you may inform us that you do not intend to resume production of sterile drug products not intended for immediate use. If you intend to resume production of sterile drug products not intended for immediate use in the future, please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. In addition to taking appropriate corrective actions, you should notify this office fifteen (15) working days prior to resuming production of any drugs intended or expected to be sterile in the future.Your response and any questions regarding the contents of this letter should be sent to compoundinginspections@fda.hhs.gov. In your response, refer to the Warning Letter Number above (# 714891) and include a subject line that clearly identifies the submission as a Response to Warning Letter.Sincerely,/S/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research______________________1We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FDCA.2The specific products repackaged by your firm are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their labeled uses.3Drugs that are repackaged are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FDCA. For additional information, you may wish to review FDA’s 2017 guidance document, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.” More specifically, the guidance sets forth conditions under which FDA does not intend to take action against drug products repackaged by pharmacies and outsourcing facilities for certain violations of the FDCA. Such conditions include, but are not limited to, the drug product that is being repackaged is a prescription drug product that (1) is approved under section 505 of the FDCA; or (2) is an unapproved drug product that appears on the drug shortage list in effect under section 506E of the FDCA, and the repackaged drug product is distributed during any period in which it is listed on that drug shortage list or during the 30 days following such period.4The drug products you repackage, such as NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections 10mg/20mg/mL, are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).

Delivery Method:Via EmailProduct:DrugsRecipient:Mikael SvenssonCEOSaNOtize1-8755 Ash StreetVancouverBCV6P 6T3Canadainfo@sanotize.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERApril 17, 2026RE: 727784Mikael Svensson:This letter is to advise you that on February 17, 2026 the United States Food and Drug Administration (FDA) reviewed your product labeling, including your websites at the internet addresses https://www.nowonder.com/ and https://sanotize.com/ where your “NOWONDER™ Nasal Cleanser” is available for purchase in the United States without a prescription.“NOWONDER™ Nasal Cleanser” is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). These violations are described in more detail below.Unapproved New Drug ViolationsYour “NOWONDER™ Nasal Cleanser” is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.Examples from the “NOWONDER™ Nasal Cleanser” product labeling, including your websites listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following: “When people around you are sick, boost your body’s natural defenses with our Nasal Wellness Spray, powered by the wonder of Nitric Oxide. Nitric Oxide is naturally produced by your immune system and helps support your ability to fight germs that can cause the common cold, flu and other illnesses.” [from your product website] “Powered by the Wonder of Nitric Oxide…Nitric Oxide safely and effectively improves your ability to fight common disease-causing germs and pathogens.” [from your product website] “The Wonder of Nitric Oxide…Clinically proven to safely and effectively kill viruses and bacteria…Nitric oxide is a powerful, naturally occurring molecule that plays a critical role in supporting your immune defense and promoting overall health. Its antiviral and antimicrobial properties help protect against common infections and illnesses.” [from your product website] “Effective…Clinical studies demonstrate that nitric oxide inhibits the replication of harmful viruses, including influenza and SARS-CoV-2, showcasing its powerful antiviral capabilities.” [from your product website] “Effective cleansing whenever exposed to harmful elements such as bacteria, viruses…” [from your product label]Your “NOWONDER™ Nasal Cleanser” drug product is not generally recognized as safe and effective (GRASE)1for use under the conditions prescribed, recommended, or suggested in its labeling and is therefore a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this drug product. Accordingly, “NOWONDER™ Nasal Cleanser” is a new drug in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). The introduction or delivery for introduction of such a product into interstate commerce violates section 301(d) of the FD&C Act, 21 U.S.C. 331(d).ConclusionThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “727784” in the subject line of your email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administrationcc:Mikael Svensson, CEONoWonder, Inc.8180 South 700 EastSuite 350Sandy, UT 84070info@nowonder.com___________________1FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “NOWONDER™ Nasal Cleanser” drug product is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling.

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-26-63Product:DrugsRecipient:Mr. Justin T. ZahnterOwnerPro Numb Tattoo Numbing Spray, LLC3778 Dixie Highway NE, Suite CPalm Bay,FL32905-2727United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-63April 14, 2026Dear Mr. Zahnter:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Pro Numb Tattoo Numbing Spray, LLC, FEI 3027228716, at 3778 Dixie Highway NE, Suite C, Palm Bay, from November 5 to 6, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).In addition, “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Additionally, these drug products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.CGMP ViolationsWe reviewed your November 13, 2025 response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).Your firm failed to adequately test batches of your drug products before release and distribution. You stated your firm does not perform finished product testing.In your response, you state you contracted a third-party laboratory to perform full release testing, and you implemented finished product specifications, Certificates of Analysis (COAs), and a standard operating procedure (SOP) for identity, strength, purity, and microbial testing.Your response is inadequate. You do not provide sufficient details about the test methods and specifications you implemented for your over-the-counter (OTC) drug products to ensure each batch of your finished products met appropriate standards before release and distribution. Also, you do not commit to performing retrospective testing of your drug product retains (reserve samples) for batches already distributed in the U.S. market.Drug product batches must be tested for identity, strength, quality, and purity before release. Without sufficient release testing, defective drug products that may pose a risk to consumers are unlikely to be detected.In response to this letter, provide:A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.Procedure(s) describing how your firm maintains drug product retains (reserve samples) for each batch manufactured at your facility.A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.The firm name, address, and supplier qualification report for the third-party laboratory or laboratories conducting your drug product release testing.2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).Your firm manufactures OTC topical analgesic drug products without adequate assurance of the quality of raw materials. For example, you did not test incoming components, such as your active pharmaceutical ingredients, for identity before using them in the manufacture of your drug products. Additionally, you relied on your suppliers’ COAs without establishing the reliability of each of your suppliers’ analyses at appropriate intervals.Without adequate testing, you do not have scientific evidence that your raw materials, including but not limited to active pharmaceutical ingredients, conform to the appropriate specifications before their use in the manufacture of your drug products. As a manufacturer, you are responsible for sampling, testing, and examining drug components before their use in production to ensure adequate quality.Your firm also used(b)(4)from an external source as a component in your finished drug products without conducting adequate testing to ensure it consistently meets the(b)(4), United States Pharmacopeia (USP) monograph specifications and appropriate microbial limits.Because(b)(4)is used as a component in your nonsterile drug products, the lack of data regarding the quality of your incoming(b)(4)poses a potential risk of introducing objectionable microbial contamination into your products.(b)(4)purposes must be suitable for its intended use and tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.In your response, you state you created SOPs for raw material receipt, quarantine, sampling, testing, handling, and approval. You also state you implemented raw material testing at a third-party laboratory and implemented testing for your(b)(4), including testing for(b)(4).Your response is inadequate. You do not provide raw material specifications, test results, and copies of your SOPs for testing raw materials, including(b)(4). You also fail to provide sufficient details demonstrating how you qualified the contract laboratory used for testing raw materials. In addition, your response does not state if you plan to perform retrospective testing for all lots of components already used to manufacture your drug products, and if you plan to establish the reliability of each of your suppliers’ analyses.In response to this letter, provide:A comprehensive, independent review of your material system, including but not limited to:o evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified;o an assessment of all materials to determine whether they are consistently of acceptable quality;o a review to ensure assigned expiration or retest dates are appropriate (supported by data);o adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions.Based on a thorough review, provide a summary of your systems corrective action and preventive action (CAPA) to remediate the supplier qualification program and prevent use of unsuitable components, containers and closures.The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your suppliers’ COAs instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.A procedure for your water testing, including sampling, that also specifies routine microbial testing of(b)(4)to ensure its acceptability for use in each batch of drug products produced by your firm.The firm name, address, and supplier qualification report, for your third-party laboratory or laboratories conducting your raw material testing.3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).You failed to demonstrate the quality attributes of your drug products remain acceptable throughout the labeled expiration period. For example, during the inspection, you indicated to the investigator you recorded microbial results on the stability-study data sheet without performing the testing and without any supporting data. You also did not record assay results on your stability-study data sheets for multiple stability time points.In your response, you explain you have established a compliant stability program, which includes establishing stability SOPs and protocols, implementing accelerated and long-term stability conditions, and submitting initial stability samples to an accredited laboratory. You also state you removed the unsupported(b)(4)expiration date while you determine whether the shelf-life is supported by data.Your response is inadequate. You do not describe in detail your stability plan with defined stability conditions, time points, and testing of the appropriate critical quality attributes for drug stability, including but not limited to microbiological and impurity testing. Also, you do not specify the expiration date that you are currently using for your finished products after you removed the(b)(4)expiration date.Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance documentData Integrity and Compliance With Drug CGMP: Questions and Answersfor guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.In response to this letter, provide:A comprehensive, independent investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global CAPA plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methodso Stability studies for each drug product in its marketed container-closure system before distribution is permittedo an ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valido detailed definition of the specific attributes to be tested at each station (timepoint)o all procedures that describe these and other elements of your remediated stability program.The current expiry date for your finished drug products.The firm name, address, and supplier qualification report for the third-party laboratory or laboratories conducting your drug product stability testing.4. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Your firm failed to validate your manufacturing processes for your OTC drug products (for example, Pro Numb Tattoo Numbing Spray 5% Lidocaine and Pro Numb Tattoo Numbing Spray 4% Lidocaine for sensitive skin). When asked to provide validation studies for your manufacturing process, you acknowledged not being familiar with process validation requirements.In addition, the process design and controls for your production did not demonstrate reproducibility or consistency in your manufacturing process. For example, for a(b)(4)to achieve your target batch size, and then you(b)(4). Also, you explained your filling process is to(b)(4), without established fill volume controls.Furthermore, you explained you perform viscosity in-process testing of your bulk drug product by looking at it, with a specification of “(b)(4),” and without using a viscometer or any other appropriate laboratory instrumentation for your viscosity determination.You did not establish scientifically sound and technically precise process parameters and process controls to ensure quality, homogeneity, and content uniformity, including fill volume of your drug products.Your response is inadequate. You do not commit to providing a detailed plan to validate your manufacturing processes.You are responsible for designing and controlling your manufacturing processes to ensure that they reproducibly yield drug products meeting predefined process parameters and quality attributes.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.See FDA’s guidance document, Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation, at https://www.fda.gov/media/71021/download.In response to this letter, provide:An assessment of each drug product process to ensure that there is a data-driven and scientifically sound program that identifies and controls all sources of variability, such that your production processes, will consistently meet appropriate specifications and manufacturing standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, sufficiency of detectability in your monitoring and testing systems, quality of input materials, and reliability of each manufacturing process step and control.A timeline for performing process performance qualification (PPQ) for each of your marketed drug products. Also provide a risk assessment and any follow up actions to be taken for the distributed drug products produced without performing any process validation studies.Process performance protocol(s), and written procedures for qualification of equipment and facilities.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control throughout the product lifecycle. Also, include your program for qualification of your equipment and facility.A comprehensive, independent assessment of your in-process monitoring and sampling operations, focusing on each upstream process step that can introduce variability. Provide your remediation plan to improve: (1) upstream process controls; (2) in-process detection of variation; and (3) sampling plans.5. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure:Establishment of adequate batch production and control records, with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).Adequate training for employees engaged in the manufacture, processing, packing, or holding of drug products (21 CFR 211.25(a)).Establishment of routine calibration and written records of calibration checks according to a written program designed to ensure proper performance of equipment used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).Adequate storage and warehousing of drug products, including but not limited to appropriate monitoring of storage conditions for temperature and humidity (21 CFR 211.142).In your response, you state you have established an independent QU; revised and approved all SOPs; remediated your batch manufacturing records; created training files, including complete GMP training of all personnel; implemented an equipment calibration program; and installed calibrated temperature and humidity data loggers with defined storage ranges to monitor your storage areas.Your response is inadequate. You do not provide sufficient information and supporting documentation to verify the adequacy and effectiveness of your corrective actions.Your firm’s quality systems are inadequate. See FDA’s guidance documentICH Q10 Pharmaceutical Quality System, as well as Quality Systems Approach to Pharmaceutical CGMP Regulations, for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71553/download and https://www.fda.gov/media/71023/download, respectively.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.A complete, independent assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.Your QU authority and responsibilities procedure, SOP-QA-001.Your organizational chart and current number of CGMP employees.Your procedure for your environmental controls and alarm limits for your storage areas.Unapproved New Drug and Misbranded Drug Violations“PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.Examples from the “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” products’ labeling, including your website, https://tattoonumbingsprays.com/, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:“PRO NUMB TATTOO NUMBING SPRAY” and “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN”“Topical Anesthetic to take away pain” [from your product labels]“Takes away Pain, Swelling, and Redness during tattoo procedures” [from your product labels]“Temporarily takes away pain, itching, and swelling associated with anorectal disorders or pain-sensitive procedures” [from your product labels]“Instantly removes pain…” [from your product website]“Tattoo Pain Relief” [from your product website]“PRO NUMB TATTOO NUMBING SPRAY”“5% lidocaine temporarily blocks pain signals in the brain” [from your product website]“PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN”“4% lidocaine temporarily blocks pain signals in the brain” [from your product website]“TKTX Deep Numbs”“Usable Range Micro Needle Pain Tattooing Body Piercing, Laser Tattoo Removal, Laser Hair Removal, Waxing, Permanent Cosmetics” [from the product label]Unapproved New Drug ViolationsBased on the above labeling evidence, “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” are intended for use as external analgesic drug products, among other intended uses.1As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the drug products identified above.Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. With respect to nonprescription external analgesic drug products, such as your “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs,” in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph, Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use (“M017”).2However, “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” do not conform to the conditions specified in M017 for the reasons described below.The labeled concentrations and/or combinations of active ingredients identified in the product labeling for “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” do not conform to the conditions of use set forth in M017. Specifically, lidocaine, an active ingredient labeled to be in all three products, is listed as lidocaine 5% in “TKTX Deep Numbs” and lidocaine hydrochloride 5% in “PRO NUMB TATTOO NUMBING SPRAY.” This concentration is above the 0.5% to 4% concentration range of lidocaine and lidocaine hydrochloride permitted under M017.10(a).As formulated, both “PRO NUMB TATTOO NUMBING SPRAY” and “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN” contain a combination of the active ingredients lidocaine and epinephrine, and “TKTX Deep Numbs” contains a combination of the active ingredients lidocaine, epinephrine, and prilocaine. None of these combinations of active ingredients in a single external analgesic drug product are permitted under M017.20. Furthermore, epinephrine, epinephrine HCl, and prilocaine are not permitted ingredients under M017, and prilocaine is not a permitted active ingredient in any final administrative order issued in accordance with section 505G.Additionally, the labeling for “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” includes indications that are not permitted for external analgesic drug products under M017.50(b). Indications related to tattooing, piercing, and/or minor cosmetic procedures are not permitted under M017 or in any other final administrative order in accordance with section 505G.Thus, “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” products do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.3Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without an approved application. Because there are no applications in effect for these products, these products are unapproved new drugs.The introduction or delivery for introduction of these unapproved new drugs into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded Drug ViolationsAdditionally, “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of any applications approved under section 505 of the FD&C Act, 21 U.S.C. 355. The introduction or delivery for introduction of misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).Drug RecallOn January 28, 2026, FDA held a teleconference with you recommending you consider removing any batches of Pro Numb Tattoo Numbing Spray and Pro Numb Tattoo Numbing Spray for Sensitive Skin currently in distribution from the U.S. market.You communicated your commitment to voluntary recall all batches of your Pro Numb Tattoo Numbing Spray drug products within expiry.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit4of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3027228716 and ATTN: Sai Dharmaraj.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research_______________________1We note that “PRO NUMB TATTOO NUMBING SPRAY” and “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN” also appear to be indicated to relieve pain associated with anorectal disorders. OTC anorectal drug products are deemed to be GRASE and not new drugs if, among other things, they conform to the conditions of use set forth in the final administrative order, Over-the-Counter Monograph M015: Anorectal Drug Products for Over-the-Counter Human Use (“M015”). (See Order ID OTC000009, available at FDA’s website OTC Monographs@FDA). These products also do not conform to the conditions set forth in this monograph.2M017 reflects the conditions set forth in the relevant final order established and in effect under section 505G; see Order ID OTC000033, available at FDA’s website OTC Monographs@FDA https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm.3FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” products are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).4i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.

根据《国家药监局农业农村部国家林草局国家中医药局关于发布〈中药材生产质量管理规范〉的公告》（2022年第22号）要求，按照《河北省中药材生产质量管理规范检查工作程序（试行）》（冀药监中药〔2024〕30号）规定，我局组织对石家庄以岭药业股份有限公司中药材泽泻种植基地，河北神威药业有限公司中药材红参、麦冬种植基地进行了《中药材生产质量管理规范》延伸检查。经综合评定，检查结果符合要求，现予以公告。附件：河北省中药材GAP延伸检查结果信息表.xls企业名称药品品种中药材品种中药材生产企业名称基地地址基地面积经纬度坐标检查结果石家庄以岭药业股份有限公司泽泻饮片、泽泻配方颗粒泽泻四川正合本草中药材有限公司四川灵萃中药材有限公司四川省眉山市彭山区谢家街道汉安村1500亩E103°49′7″，N30°13′44″符合要求河北神威药业有限公司参麦注射液红参集安市宏兴参业有限公司辽宁省宽甸满族自治县灌水镇500亩E124°38′18″，N40°52′16″符合要求辽宁省宽甸满族自治县青椅山镇500亩E124°37′16″，N40°42′38″河北神威药业有限公司参麦注射液麦冬三台县花园兴裕涪城麦冬生产专业合作社四川省绵阳市三台县老马镇里程村660亩E104°59′40.637″，N31°13′0.091″符合要求河北省药品监督管理局2026年4月21日（信息公开类型：主动公开）

行政相对人名称 昆山亿方药业有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 91320583MA1WYN0815 工商注册号 组织机构代码 税务登记号 事业单位证书号 社会组织登记证号 法定代表人 陈志 法定代表人证件类型 身份证 法定代表人证件号码 310************10 证件类型 证件号码 行政处罚决定书文号 苏药监苏药处罚〔2026〕1号 违法行为类型 违反了《中华人民共和国药品管理法》第九十八条第一款的规定，该公司的行为系销售假药 违法事实 违反了《中华人民共和国药品管理法》第九十八条第一款的规定，该公司的行为系销售假药 处罚依据 《中华人民共和国药品管理法》第一百一十六条和《中华人民共和国药品管理法实施条例》第七十五条的规定 处罚类别 没收违法所得 处罚内容 没收违法所得14862.49元。 罚款金额（万元） 没收违法所得没收非法财物的金额（万元） 1.486249 暂扣或吊销证照名称及编号 处罚决定日期 2026/04/20 处罚有效期 2026/05/06 公示截止期 2026/07/19 处罚机关 江苏省药品监督管理局 处罚机关统一社会信用代码 11320000014000394R 数据来源单位 江苏省药品监督管理局 数据来源单位统一社会信用代码 11320000014000394R 备注 公示截止期依据文件：关于进一步规范“双公示”信息归集有关工作的通知