Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Priyanka RanaPresident and Chief Pharmacy OfficerApothecary Pharma, LLC1913 Evans RoadCary,NC27513-2041United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 717972December 1, 2025Dear Ms. Rana: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 7, 2024, and most recently on January 11, 2025. From May 12, 2025, to May 15, 2025, FDA investigators inspected your facility, Apothecary Pharma, LLC located at 1913 Evans Road, Cary, NC 27513. During the inspection, the investigators noted that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA. In addition, the investigators 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 May 15, 2025. FDA acknowledges receipt of your facility’s response, dated June 9, 2025, and related attachments received July 17, 2025. FDA acknowledges that your firm ceased sterile drug production as of May 12, 2025, and notified FDA of an intent to resume sterile drug production on August 1, 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.2An 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.For a compounded drug product to qualify for the exemptions under section 503B, the labeling of the drug must include certain information (section 503B(a)(10) of the FDCA [21 U.S.C. §353b(a)(10)]).In addition, for a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b), including the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)” (section 503B(a)(1), (b)(5) of the FDCA [21 U.S.C. § 353b(a)(1), (b)(5)]).B. Failure to Meet the Conditions of Section 503BDuring the inspection, FDA investigators noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigators noted:1. Some of your facility’s drug products, such as Tirzepatide Injection 10 mg/mL and Semaglutide Injection 2.5 mg/mL, did not include the following information on the label: a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient. Additionally, some of your facility’s drug products did not include the following information on the container: information to facilitate adverse event reporting and directions for use, including, as appropriate, dosage and administration.2. Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).3Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not include a definition of what constitutes a “serious” and “unexpected” adverse event (21 CFR 310.305(b)).Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA.Specific violations are described below.C. Violations of the FDCAAdulterated Drug ProductsFDA investigators 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 investigators observed:1. An operator blocked first air by placing gloved hands directly over open sterile containers.2. An operator placed components within the ISO 5 work area that had the potential to block the movement of first air to critical in-process operations. Specifically, an operator positioned a second row of exposed vials behind a first row in the ISO 5(b)(4)laminar flow hood, obstructing first air to critical surfaces.3. An operator rested their arms on the work surface of the hood during aseptic production. This practice may introduce contamination into the ISO 5 work area.4. An operator placed their gloved hands outside the ISO 5 work area to retrieve supplies without sanitizing their gloved hands before re-entry into the ISO 5 hood.5. Personnel engaged in aseptic processing while exposing skin within the ISO 5 aseptic processing area.6. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.7. Personnel moved quickly in a critical area such that unidirectional airflow is likely to be disrupted.8. Production areas or equipment have difficult to clean and visibly rusty equipment or surfaces.9. Lack of disinfection of equipment and supplies at each transition from areas of lower quality air to areas of higher quality air.10. Failing to disinfect or change gloves frequently enough given the nature of the operations to prevent contamination. More specifically, personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with gloved hands and then proceeding with aseptic processing without changing or sanitizing gloves.FDA investigators 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. Your firm failed to establish written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)).2. 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)).3. Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)).4. Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).5. Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).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 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.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 drug products that you compound.4Under 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 505 of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.Misbranded Drug ProductsYou compound drug products 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. Consequently, their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.5The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA. Further, 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.D. Corrective ActionsWe have reviewed your facility's response to the Form FDA 483. FDA acknowledges that your firm ceased sterile drug production as of May 12, 2025, and notified FDA of an intent to resume sterile drug production on August 1, 2025.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. We acknowledge your corrective actions addressing operating with draft procedures and improper visual inspection techniques, including finalization of SOPs for Quality Unit responsibilities, Corrective and Preventive Action (CAPA), batch record review, out-of-specification (OOS) results, and retraining on the visual inspection SOP. However, your response remains inadequate because draft SOPs for Change Control, Deviations, and Risk Assessment were not addressed, and you did not assure that draft versions will not be used. In addition, you did not provide competency verification or supervisory oversight of retrained inspectors, nor a retrospective review of batches inspected under improper techniques.2. We acknowledge your actions regarding inadequate skin coverage posing a contamination risk to sterile drug products, including internal training to SOP 0003.00 with emphasis on mirror self-inspection. However, the adequacy of your response cannotbe fully evaluated because you did not provide supporting documentation, competency verification, post-retraining assessments, or updates to SOP 0003.00/procedures to enforce mirror checks. Further, although production was halted until August 1, 2025, you did not submit evidence of interim controls or monitoring results demonstrating proper gowning to assure ongoing compliance thereafter.Some of your corrective actions appear deficient:1. Regarding your firm’s failure to establish written responsibilities and procedures applicable to the quality control unit, we acknowledge your voluntary halt of production on May 12, 2025, and your commitment to implementing corrective actions by August 1,2025. However, your response is inadequate for the following reasons:a. Your response lacks a retrospective review plan for released batches(b)(4),(b)(4)and fails to include a root cause analysis for why incomplete records were initially released. You have not provided training records demonstrating staff understanding of the new SOP 1012.00 procedures or evidence that the enhanced batch record review process addresses all identified deficiencies.b. While you engaged(b)(4)Air for re-certification, you have not acknowledged(b)(4)' license revocation since 2014 or provided a plan to validate prior certifications. Your response lacks vendor qualification procedures (e.g., revising SOP 1009.00) and certification review processes. There is no assessment of previously released products manufactured in potentially uncertified environments, which compromises patient safety.2. We acknowledge your engagement of(b)(4)Air and your retraining efforts related to aseptic operations. However, your response is inadequate because:a. You did not provide detailed protocols to ensure dynamic smoke studies simulate true production with maximum equipment and personnel, nor did you define acceptance criteria or Quality Unit oversight for vendor-conducted studies.b. You failed to conduct a risk assessment for the(b)(4)Tirzepatide 10 mg/mL batches released without validated airflow studies, or to provide an impact evaluation or justification for their release.c. Critical validation gaps remain, including no commitment to perform smoke studies in the ISO 7 cleanroom and no methodologies to improve smoke volume, background contrast, or dynamic simulation.d. Aseptic technique retraining did not address specific behaviors that compromise first air (e.g., blocking critical surfaces, resting forearms on ISO 5 surfaces, leaning into hoods and exposing skin).e. You proposed no workspace/equipment modifications to ensure all vials receive unidirectional airflow, and you did not evaluate equipment configurations to mitigate this risk.3. We acknowledge your retraining to SOP 0003.00 with emphasis on mirror self inspection. However, your response is inadequate because:a. SOP 0003.00 was not updated to reflect the correct gowning sequence or to establish procedures that enforce mirror checks and supervisory oversight.b. You did not provide supporting documentation or competency verification demonstrating proper gowning technique; no post-retraining assessments were submitted.c. You did not address observed deficiencies (e.g., use of safety glasses instead of cleanroom goggles, crossing the demarcation line on the “dirty” side, and masks worn upside down).d. Procedural gaps remain regarding shoe covers over clogs when entering ISO-classified areas.e. Although operations resumed on August 1, 2025, you did not provide evidence of interim controls or monitoring results demonstrating continued compliance after August 1, 2025, or plans to assure ongoing compliance thereafter.4. We acknowledge your commitment to address the condition of the ISO 5 laminar airflow hood (LAFH) by August 1, 2025. However, your response is inadequate because:a. You did not provide essential supporting documentation such as photographic evidence, maintenance records, or updated SOPs, while providing only vague commitments to repair rust damage without specifying repair methods. No interim controls or monitoring were described to mitigate contamination risk while the compromised LAFH remained in service, including upon resumption of operations on August 1, 2025.b. The root cause analysis attributing rust to(b)(4)lacked supporting evidence and did not include revised cleaning protocols, verification, or preventive measures; dents and peeling paint were inappropriately characterized as “cosmetic.”c. Reliance on media fills, sterility tests, or prior certifications does not address equipment condition defects that can harbor contamination or disrupt airflow pattern.d. You failed to provide supporting documentation including photographs, maintenance records, engineering assessments, updated SOPs, or qualification protocols, to demonstrate the implementation and effectiveness of your proposed changes. You did not provide an impact assessment for distributed batches compounded on this LAFH or establish a robust preventive maintenance program to prevent recurrence.5. We acknowledge retraining to SOP 0004 (Ideal Conduct in Cleanroom) and SOP 2001.00 (Cleanroom Material Transfer). However, your response is inadequate because:a. You did not revise your SOPs to establish specific disinfection protocols with clear responsibilities and acceptance criteria.b. You did not provide a comprehensive CAPA plan that includes thorough root cause analysis, implementation evidence, or monitoring strategies to verify effectiveness of corrective actions.c. You failed to provide training documentation and competency assessments demonstrating that personnel can correctly perform material transfer procedures and maintain proper glove hygiene practices. The proposed sanitize-able metal tool for trash handling lacks specificity and does not mitigate immediate contamination risks during aseptic operation.d. You did not submit an ongoing compliance plan (e.g., routine observation, audit checklists, personnel monitoring targets) or interim controls upon resumption of operations on August 1, 2025.6. We acknowledge your retraining to SOP 2004 (Visual Inspection). However, your response is inadequate because:a. You failed to revise batch records and procedures to include proper defect classification (critical/major/minor), Acceptable Quality Levels (AQL) methodology, and acceptance criteria. Additionally, you did not provide an updated Form F-2004.00-01, and AQL documentation continues to be omitted from your quality control processes. You did not submit documentation demonstrating retraining effectiveness (e.g., training curriculum, attendance, competency assessments, completion dates) or supervisory oversight of inspectors.b. You failed to provide impact assessment or retrospective review of distributed lots AP-202505 through AP-202513 to determine whether visual inspection deficiencies affected product quality.c. You failed to provide finalized SOP revisions or evidence of implementation; Annexure-1 lacked sufficient detail to verify changes.d. The referenced CAPA lacked specific corrective actions, milestones, responsible owners, and effectiveness checks.Given the nature and significance of the violations identified, FDA remains concerned that your firm has not yet demonstrated that adequate correction has been properly implemented to sustain sterile drug product manufacturing in a manner fully consistent with CGMP. 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.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).]Should you continue to compound and distribute drug products that do not meet the conditions of section 503B, the compounding and distribution of your drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the Drug Supply Chain Security Act requirements.E. 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 (# 717972) 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/F. Gail Bormel, JD, RPhDirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research______________________1SeePub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).2We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FDCA.3For more information, see, FDA’s guidance, “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which can be found at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf.4The specific products made 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.5Your compounded drug products 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 Electronic Mail - Return Receipt RequestedReference #:320-26-50Product:Drugs,Over-the-Counter DrugsRecipient:Mr. Gary SchlatterCEOOraLabs, Inc.18685 East Plaza DriveParker,CO80134-9061United Statesgschlatter@oralabs.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-50March 11, 2026Dear Mr. Schlatter:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, OraLabs Inc., FEI 3001237145, at 18685 East Plaza Drive, Parker, from September 22 to 26, 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).We reviewed your October 17, 2025, response to our Form FDA 483 in detail.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).Your firm operates as both a contract and own label manufacturer of over-the-counter (OTC) drug products, including(b)(4)marketed to(b)(4). Your firm released multiple batches of OTC drug products without performing appropriate microbiological release testing. For example, on February 4, 2025, you manufactured over(b)(4)units of(b)(4)(Lot(b)(4)) without performing microbiological testing for release. Your quality unit (QU) approved and released this lot on(b)(4), and distributed it to your customer on(b)(4).In your response you confirmed that you perform microbiological testing only at your customer’s request. You also provided a justification memo which concluded “no testing required” for total aerobic microbial count, total combined yeasts/molds, and specified microorganisms based on your products being(b)(4). Your response is inadequate. FDA has encountered recalls for microbial contamination in(b)(4)drug products. Your justification memo reveals microbial growth in your drug products. While microbial proliferation risk may be lower, microorganisms can persist in your drug products. Eliminating microbial testing of your drug products is unacceptable. CGMP regulations require written procedures be established to prevent introduction of objectionable microbiological contamination in the manufacture of drug products not required to be sterile.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.A list of chemical and microbial specifications (i.e., total counts, identification of bioburden to detect objectionable microbes), including test methods, used to analyze each lot of your drug products before a lot 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 within the United States that are within expiry as of the date of this letter.o A summary of results from testing retain samples of all drug product batches within expiry. You should test all appropriate quality attributes including, but not limited to, identity and strength of active ingredients and microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an out-of-specification (OOS) result, indicate the corrective actions you will take, including notifying customers and initiating recalls.2. Your firm failed to thoroughly investigate any unexplained discrepancy or 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).Your investigations into microbiological testing failures when your customers requested such testing frequently lacked thorough root cause analysis and appropriate corrective actions and preventive actions (CAPAs). For example, you investigated total aerobic counts exceeding specification limits for(b)(4)drug product and identified the microorganism asBacillus cereus. However, you invalidated this excursion because the specific pathogens listed on the certificate of analysis were not detected. You concluded that the “most likely source of contamination would be from environmental contamination during the manufacturing process.” You lacked adequate scientific rationale to invalidate this excursion.Additionally, multiple investigations resulted in inconclusive root causes or were invalidated with inconsistent approaches that often lacked thorough manufacturing investigations, environmental sampling, and other potential sources of contamination. Your investigations inappropriately minimized the risk of these microbial excursions by stating that products had lower(b)(4)content and “product does not support growth.” Your conclusions contradict the microbial excursions detected in your test results, and your QU released the associated lots for distribution.In your response, you commit to evaluating procedures and including additional documentation for OOS results, as well as training employees. Your response does not adequately demonstrate that your firm has remediated its investigational capabilities to ensure comprehensive, well-documented, and scientifically rigorous investigations to effectively identify root causes and result in appropriate CAPAs.In response to this letter, provide:A comprehensive, independent assessment of the design and control of your firm’s manufacturing operations with a detailed and thorough review of all microbiological hazards.A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.Complete investigations into all batches with potential objectionable microbial contamination or a microbial excursion (whether or not later invalidated or inconclusive). The investigations should detail your findings regarding the root causes of the contamination.Responsibilities as a ContractorDrugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA’s guidance documentContract Manufacturing Arrangements for Drugs: Quality Agreementsat https://www.fda.gov/media/86193/download.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 3001237145 and ATTN: Bryce Hammer.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Product:DrugsRecipient:Citra100mgUnited StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 4, 2026RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetCitra100mg:This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.citra100mg.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)].As discussed below, FDA has observed that www.citra100mg.com introduces into interstate commerce unapproved and misbranded opioids. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.citra100mg.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.citra100mg.com 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 disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by 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. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, 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)].An example of an unapproved opioid you offer for sale on www.citra100mg.com is tramadol marketed as “Citra 100mg”, “Clovidol 100mg”, “Jpdol 100mg”, “Ol tram 100mg”, “OL-tram Loose Pills”, and “Trakem 100 mg”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Effective Painkillers to Treat Chronic Pain”. While there are FDA-approved versions of tramadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Citra 100mg”, “Clovidol 100mg”, “Jpdol 100mg”, “Ol tram 100mg”, “OL-tram Loose Pills”, and “Trakem 100 mg” offered by www.citra100mg.com. FDA-approved tramadol is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.FDA-approved tramadol is only available pursuant to a prescription from a licensed practitioner. Furthermore, this drug product bears a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. This boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and accidental exposure resulting in death. In addition, when these drug products are taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. By offering these drugs for sale to U.S. consumers, www.citra100mg.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug products without requiring a prescription, www.citra100mg.com jeopardizes patient safety and misbrands the drug products under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].FDA is sending this warning letter to www.citra100mg.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. 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 corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

行政处罚决定书文号：沈辽市监处罚﹝2026﹞19号处罚类别：没收违法所得处罚决定日期：2026-03-05处罚内容：没收违法所得1.5元违法行为类型：当事人的行为违反了《中华人民共和国药品管理法》第九十八条第一款“禁止生产（包括配制，下同）、销售、使用假药、劣药。"的规定，已构成销售劣药“清气化痰丸”的违法行为。违法事实：经查明，当事人于2024年9月14日从辽宁新润医药有限公司购进标示为湖北瑞华制药有限公司生产，批号为240529的“清气化痰丸”5盒，每盒进价9.5元；2025年1月17日上述批次“清气化痰丸”经四川省药品检验研究院（四川省医疗器械检测中心）检验（检验报告编号：YP2025A01274），结论为不符合《中国药典》规定。截至2025年12月15日我局立案时止，当事人已以11元/盒售出该药品1盒，剩余4盒药品被辽宁新润医药有限公司召回。处罚依据：依据《中华人民共和国药品管理法》第一百一十七条“生产、销售劣药的，没收违法生产、销售的药品和违法所得，并处违法生产，销售的药品货值金额十倍以上二十倍以下的罚款；违法生产、批发的药品货值金额不足十万元的，按十万元计算，违法零售的药品货值金额不足一万元的，按一万元计算；情节严重的，责令停产停业整顿直至吊销药品批准证明文件、药品生产许可证、药品经营许可证或者医疗机构制剂许可证。"和《中华人民共和国药品管理法实施条例》第七十五条“药品经营企业、医疗机构未违反《药品管理法》和本条例的有关规定，并有充分证据证明其不知道所销售或者使用的药品是假药、劣药的，应当没收其销售或者使用的假药、劣药和违法所得；但是，可以免除其他行政处罚”的规定。处罚机关：沈阳市辽中区市场监督管理局处罚机关统一社会信用代码：11210122MB0Q12814J数据来源单位：沈阳市辽中区市场监督管理局数据来源单位统一社会信用代码：11210122MB0Q12814J

按照《关于加强药品经营企业歇业管理有关问题的通知》（皖食药监市〔2008〕180号）规定，同意下列企业在《药品经营许可证》有效期内歇业。    企业歇业期间，不得开展药品经营活动。如企业在许可证有效期内恢复经营，须向省局提交恢复经营申请及恢复经营专项审计报告和企业严格执行《药品经营质量管理规范》的承诺，经同意后发还《药品经营许可证》正副本。企业名称法定代表人/负责人许可证编号许可证有有效期至经营地址仓库地址经营范围海王医药安庆有限公司鲍炳勇/张军皖AA5560004732029.05.25安庆市开发区晋熙路5号1栋5-6层安徽省安庆市开发区晋熙路5号1栋1-3层中成药、化学药（原料药及制剂）生物制品、麻醉药品、第一类精神药品、第二类精神药品、蛋白同化制剂、肽类激素（上述经营范围含冷藏药品）（麻醉、第一类精神药品供药责任区域为安庆市辖区）***               安徽省药品监督管理局                            2026年3月17日

经查，王自力等8人的执业药师注册单位与实际工作单位不符，属于《执业药师职业资格制度规定》第二十八条第二款、《执业药师注册管理办法》第三十四条规定的挂靠。我局依法定权限、程序作出了行政处理决定，现将行政处理结果公告如下：序号姓名注册单位注册证号行政处理结果备注1王自力福建晋江市济仁大药房有限公司352225051009三年内不予注册，并将个人不良信息记入全国执业药师注册管理信息系统当事人执业注册证书已于行政处理决定前主动注销2王玲玲晋江市合隆堂大药房有限公司351222050555三年内不予注册，并将个人不良信息记入全国执业药师注册管理信息系统当事人执业注册证书已于行政处理决定前主动注销3陈明菜龙海市浮宫回生堂药店351225060230撤销当事人《执业药师注册证》，三年内不予注册，并将个人不良信息记入全国执业药师注册管理信息系统4吴丽丽加上（福建）医药有限公司352223060538撤销当事人《执业药师注册证》，三年内不予注册，并将个人不良信息记入全国执业药师注册管理信息系统5郑燕梅漳州贤泽医药有限公司隆教分店352223060181撤销当事人《执业药师注册证》，三年内不予注册，并将个人不良信息记入全国执业药师注册管理信息系统6王颖福州市鼓楼区双安药店湖头街店351222010180三年内不予注册，并将个人不良信息记入全国执业药师注册管理信息系统当事人执业注册证书已于行政处理决定前主动注销7李晟福州市鼓楼区达康明药店351222010026三年内不予注册，并将个人不良信息记入全国执业药师注册管理信息系统当事人执业注册证书已于行政处理决定前主动注销8周苏键福州市鼓楼区世安堂药房351221011658三年内不予注册，并将个人不良信息记入全国执业药师注册管理信息系统当事人执业注册证书已于行政处理决定前主动注销

　　根据《药品管理法》、《药品生产监督管理办法》有关规定，经现场检查并综合评定，现将福建省宝诺医药研发有限公司《药品生产质量管理规范》符合性检查结果公告。企业名称检查地址检查范围检查时间类型检查结果福建省宝诺医药研发有限公司（受托方：江苏万高药业股份有限公司）。1.持有人检查地址（持有人注册地址）：厦门市海沧区海沧大道567号厦门中心E座909单元；2.对受托方（延伸检查）：江苏省海门经济技术开发区定海路688号。1.检查范围：磷酸奥司他韦干混悬剂[规格：0.36g（按C16H28N2O4计）；批准文号：国药准字H20253011]；2.生产类型：委托生产；3.生产线：受托方固体制剂车间101生产线。1.持有人检查时间：2025年12月24日下午-12月26日上午；2.延伸检查时间：2026年01月27日-01月29日。依申请符合　　福建省药品监督管理局　　2026年3月17日

根据《药品管理法》、《药品生产监督管理办法》有关规定，经现场检查并综合评定，现将福建古田药业有限公司《药品生产质量管理规范》符合性检查结果公告。企业名称生产地址检查范围检查时间类型检查结论福建古田药业有限公司福建省古田县城西街道松安一支路1号口服固体制剂车间：片剂2号线、胶囊剂2号线（含中药提取车间中药材前处理2号线、中药提取2号线）；小容量注射剂车间：注射剂3号线、注射剂4号线；小容量注射剂车间：注射剂1号线、注射剂2号线（含中药提取车间中药材前处理2号线、中药提取4号线）2026年1月20日～1月23日依申请符合福建省药品监督管理局2026年3月13日

序号行政处罚决定书文号案件名称违法企业名称或违法企业自然人姓名违法企业组织机构代码法定代表人姓名主要违法事实行政处罚的种类和依据作出处罚的机关名称和日期备注1黔药监行罚〔2026〕7号贵州康华医药有限公司销售劣药碳酸氢钠注射液案贵州康华医药有限公司统一社会信用代码：91520113MAAJRTN72L田健销售劣药碳酸氢钠注射液处罚种类：1.没收非法财物；2.没收违法所得。处罚依据：《中华人民共和国药品管理法》第七十五条贵州省药品监督管理局2026年3月4日

部分医用耗材及企业信息变更公示(2026年第五批)