Delivery Method:Via EmailProduct:DrugsRecipient:Venkata Vamsi Krishna KothuriDistacart Inc.883 N Shoreline Blvd, Suite B220Mountain View,CA94043United Stateshappy@distacart.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERNovember 17, 2025RE: 716212Venkata Vamsi Krishna Kothuri:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://www.distacart.com in September 2025. The FDA has observed that your website offers “SBL Malaria Officinalis Dilution,” “Allen Depression Drops A79,” “Wheezal WL2 Drops,” “Bjain Omeo Asthma Medicated Syrup,” “Dr. Reckeweg R62,” “Lord’s Eyerite Eye Drops,” “Sitaram Ayurveda Elaneer Kuzhamb,” “Dr. M.S. Basu’s Isotine Eye Drop,” and “SBL Euphrasia 10% Eye Drops” (hereinafter Distacart products) for sale in the United States. Based on our review, these 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). As explained further below, introducing or delivering these products 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).Your Distacart products are especially concerning from a public health perspective. As described below, the labeling of your unapproved “SBL Malaria Officinalis Dilution,” “Allen Depression Drops A79,” “Wheezal WL2 Drops,” “Bjain Omeo Asthma Medicated Syrup,” and “Dr. Reckeweg R62” drug products includes claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as malaria, gout, asthma, measles, and depression, and may cause consumers to forgo, delay, or discontinue medical treatments that have been found safe and effective for such conditions through the FDA review process. In addition, your unapproved “Lord’s Eyerite Eye Drops,” “Sitaram Ayurveda Elaneer Kuzhamb,” “Dr. M.S. Basu’s Isotine Eye Drop,” and “SBL Euphrasia 10% Eye Drops” drug products are concerning because ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.Based on a review of your website, your Distacart products 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. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:SBL Malaria Officinalis DilutionOn the webpage https://www.distacart.com/products/sbl-homeopathy-malaria-officinalis-dilution?variant=41391178743967“It is a homeopathic remedy for constipation, gout, etc. It is conventionally used for taking care of Malaria and leg cramps.”“Key Benefits:o It may help in taking care of malaria and leg crampso may [sic] used to reduce symptoms like chilling and shiveringo may Assists [sic] in taking care of Live infections, Neuralgia, and Rheumatismo may [sic] Beneficial for taking care of inflammation of the eyes with heat, redness, and burning”Allen Depression Drops A79On the webpage https://www.distacart.com/products/allen-homeopathy-a79-depression-drops:From the product packaging: “Indications: Hopelessness, Low mood, Reduced energy, Appetite disturbance, Loss of libido, Insomnia, Low self-esteem, Suicidal thoughts, unusual fears, Pessimism, Ideas of worthlessness.”Wheezal WL2 DropsOn the webpage https://www.distacart.com/products/wheezal-wl2-asthma-drops?variant=40335275786399:From the product packaging:“AsthmaRelieves Tightening Of The Chest And Opens Airways”Bjain Omeo Asthma Medicated SyrupOn the webpage https://www.distacart.com/products/bjain-homeopathy-omeo-asthma-syrup?variant=42818832564383:From the product packaging:“The Homoeopathic [sic] BronchodilatorDifficulty in breathingWheezingTightness of the chestAsthmatic Cough”Dr. Reckeweg R62On the webpage https://www.distacart.com/products/dr-reckeweg-r62-measles-morbillin-drop:“Dr. Reckeweg R62 Measles (Morbillin) Drop - 22 ml”From the product packaging: “Morbillin - Inflammation of mucous membranes”Lord’s Eyerite Eye DropsOn the webpage https://www.distacart.com/products/lords-homeopathy-eyerite-eye-drops:From the product packaging:“Indications:o Conjunctivitiso Redness of eyeso Wateringo Paino Irritationo Dry Eyes”Sitaram Ayurveda Elaneer KuzhambOn the webpage https://www.distacart.com/products/sitaram-ayurveda-elaneer-kuzhambu-eye-drops:From the product packaging: “Remedy For All Eye Disease”Dr. M.S. Basu’s Isotine Eye DropOn the webpage https://www.distacart.com/products/dr-basus-isotine-eye-drops?variant=41382453215391:From the product packaging: “Use in Immature Cataract, Myopia, Hypermetropia, Glaucoma, Diabetic Retinopathy, Macular Degeneration, Retinitis, Pigmentosa, Colour Blindness etc.”SBL Euphrasia 10% Eye DropsOn the webpage https://www.distacart.com/products/sbl-homeopathy-euphrasia-10-eye-drops?variant=41212397551775:From the product packaging:“Indication:For conjunctivitis, redness of eyes, watering, pain, irritation, photophobia, dry eyes.”Your Distacart 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 use under the above-described conditions prescribed, recommended, or suggested in their 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 approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).We recognize that your “SBL Malaria Officinalis Dilution,” “Allen Depression Drops A79,” “Wheezal WL2 Drops,” “Bjain Omeo Asthma Medicated Syrup,” “Dr. Reckeweg R62,” “Lord’s Eyerite Eye Drops,” and “SBL Euphrasia 10% Eye Drops” drug products are labeled as homeopathic drugs. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.ConclusionThe violations cited in this letter are 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 lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen 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 fifteen 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 “716212” in the subject line of the email.Sincerely,/S/Brad Pace, JDAssociate DirectorOffice of Unapproved and Labeling ComplianceSigned on behalf of:Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

Delivery Method:Via Electronic Mail - Return Receipt RequestedProduct:DrugsRecipient:Andrew C. CorbinCEO/CFOWells Pharma of Houston, LLC9265 Kirby DriveHouston,TX77054-2520United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 713015November 7, 2025Dear Mr. Corbin: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 March 9, 2020, and most recently on November 5, 2024. From March 17, 2025, to March 28, 2025, an FDA investigator inspected your facility, Wells Pharma of Houston, LLC located at 9265 Kirby Drive, Houston, Texas 77054. During the inspection, the investigator 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 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 March 28, 2025. FDA acknowledges receipt of your facility’s response, dated May 9, 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.In addition, 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)]).Furthermore, 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, CFR (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, the FDA investigator noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigator noted:1. Some of your facility’s drug products, such as Fentanyl 50 mcg/10 mL in 0.9% Sodium Chloride and Phenylephrine Hydrochloride 800 mcg/10 mL in 0.9% Sodium Chloride, did not include the following statement on the label: “This is a compounded drug.”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, CFR (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 complete definition of what constitutes a “serious” adverse event as it is missing the following language: “Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.” (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 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. An operator placed components within the ISO(b)(4)work area that had the potential to block the movement of first air to critical in-process operations.2. Your media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.3. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO(b)(4)area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.4. Cracked plexiglass siding with an appearance of yellowish brown and black discoloration around metal brackets affecting your ISO(b)(4)laminar airflow hoods (LAFHs).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. 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)).2. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).3. 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).4. Your firm failed to establish adequate 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)).5. Your firm failed to exercise strict control over labeling issued for use in drug product labeling operations (21 CFR 211.125(a)).6. 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)).7. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).8. Your firm failed to establish an adequate system for maintaining 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.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 FDCAMisbranded 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.Some of your corrective actions appear deficient:1. Regarding your smoke studies, your response stated an outside contractor will perform new smoke studies in May 2025 and other process and procedure updates will be completed in the third quarter of 2025. We have not received the results of your new smoke study and acknowledge procedure updates may be pending. However, your response did not address the risk to current processing and potential impact to distributed product due to the deficient smoke study of your ISO(b)(4)LAFHs not performed under normal dynamic conditions. This is a repeat violation as your firm was also cited for inadequate smoke studies in your ISO(b)(4)LAFH during the 2021 FDA inspection.2. As it relates to your environmental monitoring (EM) program, your response refers to numerous procedures and corrective and preventative actions (CAPAs) that were either updated or will be revised to address the concerns identified, but deficiencies remain. For example, SOP HOU-QC-018 effective April 7, 2025, provided to “serve as corrections to this observation” still specifies alert(b)(4)CFU and action(b)(4)CFU levels for viable surface samples within your ISO(b)(4)areas. Any microbial contamination in the ISO(b)(4)area is considered an insanitary condition. Any microbial contamination within the ISO(b)(4)area is a serious concern and upon recovery, your firm should immediately assess the impact on drug products produced. This assessment should include a thorough evaluation of how contamination could have entered this critical area, and over what period of time the contamination could have existed, as well as drug products that remain on the market that could be affected.Your response also stated that modifications to this procedure and others were already in progress as part of change control CC-HOU-2025-005 signed off on March 11, 2025. However, the change control does not address the specific deficiencies found by our investigator. For example, your response did not address the deficiencies regarding when active viable EM process sampling occurs. The timing of this sampling should be based on risk and adequate for the duration of your manufacturing process, not just at the(b)(4)of a batch.Furthermore, your response does not address the root cause as to why employees are not following proper fingertip sampling technique as outlined in your procedures nor the impact of this practice on lots distributed.3. You initiated deviation DEV-HOU-2025-002 for not incubating EM plates at the specified time and temperature per your procedure. Your investigation did not assess product impact nor provide adequate justification for release of the batches. We acknowledge you plan to improve your investigation process, but your response did not address the specific issue cited on the Form FDA 483, inadequately incubated EM plates that affected approximately(b)(4)batches of drug product lots intended to be sterile. You determined the root cause was due to short staffing. Your response lacks assurance that your EM testing results are accurate and reliable. In addition, your response failed to address if other tasks that may affect product release have also been missed due to short staffing.4. Your visual inspection (VI) process and VI training program remain deficient. Your response stated CAPA-HOU-2025-003 was initiated on March 1, 2025, and that your VI procedures will be updated. However, your response did not describe how the planned procedural updates will address all the observations noted by our investigator.5. Your response related to your disinfectant efficacy study referenced an existing CAPA for cleaning validation (CV) requirements and you also noted that an updated study was initiated. You noted that the CV study was not completed as expected, so you opened a new CAPA-HOU-025-004 on March 5, 2025. However, the new CAPA appears to focus on preventing cross-contamination from beta-lactam residues but doesn’t address the findings noted by our investigator.6. Regarding the(b)(4)totes used to transfer materials from non-classified areas into the ISO(b)(4)cleanroom suite, your response referenced an existing CAPA for CV and you also noted that updated studies were initiated. Your response did not address the(b)(4)bottoms and handles on the totes and how you plan to minimize the potential ingress of microbial contamination.7. We acknowledge that you replaced the cracked plexiglass panels on the(b)(4)impacted ISO(b)(4)LAFHs. However, it is unknown how long the cracked plexiglass existed on the ISO(b)(4)LAFHs, and you did not perform an investigation or risk assessment to mitigate any potential concerns with distributed product.We are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:1. We acknowledge that training on aseptic technique was performed following the FDA inspection. However, the training slides provided did not show how the training documentation will prevent employees from blocking first air, nor did it provide details on how your aseptic pharmacy technicians will fill drug product intended to be sterile and remove air from a syringe in a manner that does not compromise first pass air. You stated that a checklist will be developed under change control CC-HOU-2025-028 and that implementation of routine walkthroughs will provide risk mitigation pending completion of procedural edits. Your response also stated that “aseptic technique is highly behavior based, ongoing monitoring and correction and intensive training and retraining provides a good measure of risk mitigation.” We agree with your statement that “additionally, the risk to the product/patient is that poor aseptic technique could result in product that is potentially microbially contaminated.” However, you did not provide a copy of the checklist nor evidence of completed walkthroughs to review.2. As it relates to your media fills, your response stated that a matrix, to include “all products, product sizes, container closure systems, etc.,” shall be developed and where significant gaps are identified, a media fill will be executed in June 2025. It is unclear if you have executed new media fills as we have not received an updated response. Your response also stated that CAPA-HOU-2025-010 was initiated to perform an evaluation of all processes related to media fill and process validation, and because of the CAPA investigation corrective actions shall be identified. We acknowledge your tentative completion date for end of the third quarter 2025 for this action. Therefore, we are not able to assess the adequacy of your media fills and corrective actions, nor the impact, if any, to distributed product due to inadequately executed media fills. It is important that your media fills include all equipment used in manufacturing of drug products, represent your actual operations including your various batch sizes and aseptic operators, and simulates your most challenging and stressful conditions of your aseptic manufacturing operations.3. Your EM procedures do not provide instructions for performing EM sampling of difficult to clean areas. Per your response, you initiated CAPA-HOU-025-009 but did not provide an update detailing your assessment of procedures HOU-QC-005, HOU-QC-009, and HOU-QC-014. Your response stated identification of hardest to reach clean areas shall be provided for each type of equipment, utensil, or other components used in production. Your response also stated that EM procedures will be updated, combined, or modified as necessary and that your corrective actions will be implemented by June 27, 2025. We have not received these procedures to assess the adequacy of your corrective actions.4. We acknowledge your statement that you performed immediate training of all labeling technicians in response to concerns noted with your control of labeling operations. However, your response did not provide any details regarding the training nor evidence showing training was completed. We acknowledge your commitment that your corrective actions for procedural and possible physical layout updates would be completed by the end of July 2025. We have not received the revised procedures to assess the adequacy of your corrective actions.5. We acknowledge you have consulted with a third-party firm to provide temperature mapping and qualification of equipment at your facility to include your(b)(4). You stated these activities and validation of the(b)(4)will be completed by May 16, 2025. We have not received any documentation showing these activities were completed. Equipment used for compounding in your ISO(b)(4)areas including goggles may impact product quality if they are not properly sterilized.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).]In addition, regarding issues related to the conditions of section 503B of the FDCA, your corrective actions appear adequate: You submitted CAPA-HOU-2025-014 which indicates you will identify process gaps for complaints and revise associated procedures to address identified gaps, including “HOU-QA-041 Pharmacovigilance Procedure for Adverse Events.” Additionally, in CC-HOU-2025-039, you also state that you will “[r]eview all commercial product labels and update to include the phrase ‘This is a compounded drug’ OR ‘This is a repackaged drug’ as appropriate.”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.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.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 (# 713015) 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 Researchcc: Lisa G. HawkinsSenior Vice President of QualityWells Pharma of Houston, LLC9265 Kirby DriveHouston, Texas 77054-2520___________________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).

行政相对人名称 江苏嘉得医疗设备有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 91321181791069740F 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 毛毳 法定代表人证件类型 法定代表人证件号码 证件类型 证件号码 行政处罚决定书文号 苏药监镇处字〔2025〕4号 违法行为类型 《医疗器械监督管理条例》第三十五条第一款的规定 违法事实 生产经注册不符合产品技术要求便携式吸痰器的行为，违反了《医疗器械监督管理条例》第三十五条第一款的规定 处罚依据 依据《医疗器械监督管理条例》第八十六条第一款第（一）项的规定 处罚类别 罚款 处罚内容 罚款伍万柒仟陆佰元 罚款金额（万元） 5.760000 没收违法所得没收非法财物的金额（万元） 暂扣或吊销证照名称及编号 处罚决定日期 2025/11/25 处罚有效期 2026/05/25 公示截止期 2026/11/25 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

行政相对人名称 扬州华士达日化有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 91321016MA1MJ0FH7R 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 许忠华 法定代表人证件类型 身份证 法定代表人证件号码 3****************4 证件类型 证件号码 行政处罚决定书文号 苏药监扬处罚〔2025〕37号 违法行为类型 生产经营不符合技术规范的化妆品的行为；违反了《化妆品监督管理条例》第六条规定 违法事实 扬州华士达日化有限公司，生产经营不符合技术规范的化妆品的行为；违反了《化妆品监督管理条例》第六条规定，依据《中华人民共和国行政处罚法》第二十八条第一款、《化妆品监督管理条例》第六十条第二项规定，应予处罚。 处罚依据 依据《中华人民共和国行政处罚法》第二十八条第一款、《化妆品监督管理条例》第六十条第二项规定 处罚类别 罚款;没收违法所得、没收非法财物 处罚内容 罚款贰万壹仟元整；没收违法所得壹仟零伍拾肆元整 罚款金额（万元） 2.1 没收违法所得没收非法财物的金额（万元） 0.1054 暂扣或吊销证照名称及编号 处罚决定日期 2025/11/25 处罚有效期 2026/05/25 公示截止期 2028/11/25 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：市场监督管理行政处罚信息公示规定。罚款金额已确认。

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的公告》（2022年第22号）和《黑龙江省药品监督管理局 黑龙江省农业农村厅 黑龙江省林业和草原局 黑龙江省中医药管理局关于推动实施的通告》的要求，2025年10月23日－10月25日，我局组织对佳木斯华润三九中医药传承创新有限责任公司基地开展延伸检查（中药材符合性检查），结果为符合GAP要求。特此通告。黑龙江省药品监督管理局2025年11月25日附件                                    中药材GAP符合性延伸检查结果被检查主体被检查品种中药材品种基地建设单位基地面积（亩）基地地址经纬度坐标本次检查预计产量检查结果佳木斯华润三九中医药传承创新有限责任公司板蓝根饮片、大青叶饮片板蓝根、大青叶泰来县万成中药材种植专业合作社1000亩齐齐哈尔市泰来县宁姜蒙古族乡好新村、黄花村地理位置:点位1：东经123°59′10”、北纬46°34′91”点位2：东经123°58′60”、北纬46°35′20”点位3：东经123°58′84”、北纬46°29′04”点位4：东经123°59′10”、北纬46°34′50”200吨、50吨符合要求

江西双福医疗用品有限公司报告，由于质量问题等原因，江西双福医疗用品有限公司对其生产的远红外止痛贴(注册备案号:赣械注准20192090283)主动召回，召回级别为三级,涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表2025-11-25