| {"cfr_code": "21 CFR 120.8(a)", "violation_type": "HACCP Plan", "severity_rating": "Critical", "raw_observation": "Further, you must have and implement a written HACCP plan whenever a hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing, as required by 21 CFR 120.8(a).", "corrective_action_plan": "Have and implement a written HACCP plan for the juice products whenever the hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing. The plan must identify control measures and critical control points for the hazards identified in the hazard analysis, including biological hazards from environmental contamination during non-aseptic blending and filling operations, biological hazards from pathogen growth due to time/temperature abuse during processing, and physical hazards (glass fragments) from glass bottling.", "synthetic_instruction": "An FDA inspection revealed that Wellmill, LLC dba Vitamix Laboratories did not have and implement a written HACCP plan under 21 CFR 120.8(a). What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 120.8(a) occurs when a juice processor fails to have and implement a written HACCP plan whenever a hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing. In this observation, Wellmill, LLC dba Vitamix Laboratories did not have a HACCP plan appropriate for the juice products. The firm's hazard analysis concluded that no food hazards are reasonably likely to occur, but it did not adequately address biological hazards from environmental contamination during non-aseptic blending and filling operations, biological hazards from pathogen growth due to time/temperature abuse during processing, and physical hazards (glass fragments) as product is bottled in glass containers. Because these hazards are reasonably likely to occur, the firm must have and implement a written HACCP plan. To remediate, the firm must develop and implement a written HACCP plan that identifies control measures and critical control points for the hazards identified in the hazard analysis, including the specific biological and physical hazards noted.", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wellmill-llc-dba-vitamix-laboratories-725655-04202026", "company": "Wellmill, LLC dba Vitamix Laboratories", "issue_date": "04/20/2026"} | |
| {"cfr_code": "21 CFR 120.24(a)", "violation_type": "Process Validation", "severity_rating": "Critical", "raw_observation": "Further, you must apply a process that achieves a 5-log reduction of the pertinent microorganism in the juice, to comply with 21 CFR 120.24(a). Under 21 CFR 120.24, processors must apply a 5-log reduction of the pertinent pathogen to juice in the facility where the final product is packaged. Your firm blends and fills the juice at ambient temperature without applying a process to produce the required minimum 5-log reduction at your facility. There is no indication that you have validated or are applying a control step to achieve the required 5-log reduction, nor that you have controls to prevent recontamination.", "corrective_action_plan": "Apply a process that achieves a 5-log reduction of the pertinent microorganism in the juice at the facility where the final product is packaged. Validate and implement a control step to achieve the required 5-log reduction, and establish controls to prevent recontamination. Ensure that the 5-log pathogen reduction process and final product packaging are performed within a single production facility operating under current good manufacturing practices, as required by 21 CFR 120.24.", "synthetic_instruction": "An FDA inspection revealed that Wellmill, LLC dba Vitamix Laboratories did not apply a process to achieve a 5-log reduction under 21 CFR 120.24(a). What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 120.24(a) occurs when a juice processor fails to apply a process that achieves a 5-log reduction of the pertinent microorganism in the juice. In this observation, Wellmill, LLC dba Vitamix Laboratories blends and fills the juice at ambient temperature without applying a process to produce the required minimum 5-log reduction at its facility. There is no indication that the firm has validated or is applying a control step to achieve the required 5-log reduction, nor that it has controls to prevent recontamination. Additionally, the single facility requirement under 21 CFR 120.24 mandates that juice processors apply the minimum 5-log pathogen reduction process and perform final product packaging within a single production facility operating under current good manufacturing practices; the firm has not demonstrated compliance with this requirement. To remediate, the firm must validate and apply a process that achieves a 5-log reduction of the pertinent pathogen at the facility where the final product is packaged, implement controls to prevent recontamination, and ensure that the 5-log reduction process and final product packaging are performed within a single production facility operating under current good manufacturing practices.", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wellmill-llc-dba-vitamix-laboratories-725655-04202026", "company": "Wellmill, LLC dba Vitamix Laboratories", "issue_date": "04/20/2026"} | |
| {"cfr_code": "21 CFR 211.84(d)(1) & 211.84(d)(2)", "violation_type": "Component Testing and Supplier Verification", "severity_rating": "Critical", "raw_observation": "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)).", "corrective_action_plan": "Establish and implement written procedures to conduct at least one identity test on each component of a drug product. Additionally, validate and establish the reliability of the component supplier’s test analyses at appropriate intervals, and maintain records of these activities.", "synthetic_instruction": "An FDA inspection revealed that Babikian Healthcare Products CJSC did not conduct at least one test to verify the identity of each component of a drug product and failed to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals under 21 CFR 211.84(d)(1) & 211.84(d)(2). What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 211.84(d)(1) & 211.84(d)(2) occurs because Babikian Healthcare Products CJSC failed to perform at least one identity test on each component of a drug product and failed to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals. To remediate, the firm must establish and implement written procedures to conduct at least one identity test on each component, validate and establish the reliability of the supplier’s test analyses at appropriate intervals, and maintain records of these activities.", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/babikian-healthcare-products-cjsc-730513-09212026", "company": "Babikian Healthcare Products CJSC", "issue_date": "09/21/2026"} | |
| {"cfr_code": "21 CFR 211.165(a) and 211.165(b)", "violation_type": "Batch Release Testing", "severity_rating": "Critical", "raw_observation": "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. Your firm also failed to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).", "corrective_action_plan": "Establish and implement written procedures to perform appropriate laboratory determination of satisfactory conformance to final specifications for each batch of drug product, including identity and strength of each active ingredient, prior to release. Also, conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms, and maintain records of these tests.", "synthetic_instruction": "An FDA inspection revealed that Babikian Healthcare Products CJSC failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications, including identity and strength of each active ingredient, prior to release, and failed to conduct appropriate laboratory testing for each batch required to be free of objectionable microorganisms under 21 CFR 211.165(a) and 211.165(b). What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 211.165(a) and 211.165(b) occurs because Babikian Healthcare Products CJSC failed to perform appropriate laboratory determination of satisfactory conformance to final specifications for each batch of drug product, including identity and strength of each active ingredient, prior to release, and failed to conduct appropriate laboratory testing for each batch required to be free of objectionable microorganisms. To remediate, the firm must establish and implement written procedures to perform such laboratory determinations and testing, and maintain records of these activities.", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/babikian-healthcare-products-cjsc-730513-09212026", "company": "Babikian Healthcare Products CJSC", "issue_date": "09/21/2026"} | |
| {"cfr_code": "21 CFR 211.22", "violation_type": "Quality Control Unit", "severity_rating": "Critical", "raw_observation": "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).", "corrective_action_plan": "Ensure the quality control unit exercises its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity. This includes establishing adequate QU authority and procedures as required by 21 CFR 211.22(a) & 211.22(d).", "synthetic_instruction": "An FDA inspection revealed that Babikian Healthcare Products CJSC’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 under 21 CFR 211.22. What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 211.22 occurs because Babikian Healthcare Products CJSC’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. To remediate, the firm must ensure the quality control unit exercises its responsibility, including establishing adequate QU authority and procedures as required by 21 CFR 211.22(a) & 211.22(d).", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/babikian-healthcare-products-cjsc-730513-09212026", "company": "Babikian Healthcare Products CJSC", "issue_date": "09/21/2026"} | |
| {"cfr_code": "21 CFR 1.502(a)", "violation_type": "FSVP", "severity_rating": "Critical", "raw_observation": "You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for some of the foods you import, including each of the following foods:", "corrective_action_plan": "Develop, maintain, and follow a written FSVP for each food you import, including the foods identified in the letter, in accordance with 21 CFR 1.502(a).", "synthetic_instruction": "An FDA inspection revealed that Fil-Bay Import, Inc. did not develop, maintain, and follow an FSVP under 21 CFR 1.502(a). What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 1.502(a) occurs when an importer fails to develop, maintain, and follow an FSVP for the foods it imports. The FDA inspection found that Fil-Bay Import, Inc. did not develop an FSVP for some of the foods it imports. To remediate, Fil-Bay Import, Inc. must develop, maintain, and follow a written FSVP for each food it imports, including the foods identified in the letter, as required by 21 CFR 1.502(a).", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fil-bay-import-inc-734615-07202026", "company": "Fil-Bay Import, Inc.", "issue_date": "07/20/2026"} | |
| {"cfr_code": "21 CFR 1.502(a)", "violation_type": "FSVP", "severity_rating": "Critical", "raw_observation": "You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including each of the following foods:", "corrective_action_plan": "Develop, maintain, and follow a written FSVP for each imported food in accordance with 21 CFR 1.502(a), including hazard analysis, evaluation of the foreign supplier's performance, and supplier verification activities, and retain records documenting the FSVP.", "synthetic_instruction": "An FDA inspection revealed that Bo Wah Enterprises Inc did not develop, maintain, and follow an FSVP under 21 CFR 1.502(a). What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 1.502(a) occurs because Bo Wah Enterprises Inc did not develop, maintain, and follow an FSVP for any of the foods it imports. The regulation requires the importer to develop, maintain, and follow an FSVP for each food it imports. To remediate, Bo Wah Enterprises Inc must develop a written FSVP for each imported food, maintain it, and follow it, including conducting a hazard analysis, evaluating the foreign supplier's performance, and performing supplier verification activities, while retaining records of these actions.", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bo-wah-enterprises-inc-736539-08132026", "company": "Bo Wah Enterprises Inc", "issue_date": "08/13/2026"} | |
| {"cfr_code": "21 CFR 211.165(a)", "violation_type": "Batch Release", "severity_rating": "Critical", "raw_observation": "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)).", "corrective_action_plan": "Establish and implement written procedures to ensure that, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications, including the identity and strength of each active ingredient, is performed prior to release. This includes defining final specifications, conducting the required laboratory testing, and documenting the results before batch release.", "synthetic_instruction": "An FDA inspection revealed that Stream2Sea, LLC did not 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 under 21 CFR 211.165(a). What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 211.165(a) occurs when a firm releases a batch of drug product without first performing appropriate laboratory determination that the batch conforms to final specifications, including the identity and strength of each active ingredient. The regulation requires that such testing be conducted prior to release. To remediate, Stream2Sea, LLC must establish and follow written procedures to ensure that each batch undergoes appropriate laboratory testing for conformance to final specifications, including identity and strength of each active ingredient, before release. The firm must also document the testing and results, and ensure that no batch is released without satisfactory conformance.", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stream2sea-llc-718983-02022026", "company": "Stream2Sea, LLC", "issue_date": "02/02/2026"} | |
| {"cfr_code": "21 CFR 211.84(d)(1) and 211.84(d)(2)", "violation_type": "Component Testing", "severity_rating": "Critical", "raw_observation": "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) and 211.84(d)(2)).", "corrective_action_plan": "Establish and implement written procedures to conduct at least one test to verify the identity of each component of a drug product. Additionally, validate and establish the reliability of component supplier’s test analyses at appropriate intervals. This includes performing identity testing on each component, and either conducting supplier qualification activities or periodic verification of supplier test results.", "synthetic_instruction": "An FDA inspection revealed that Stream2Sea, LLC failed to conduct at least one test to verify the identity of each component of a drug product, and failed to validate and establish the reliability of its component supplier’s test analyses at appropriate intervals under 21 CFR 211.84(d)(1) and 211.84(d)(2). What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 211.84(d)(1) and 211.84(d)(2) occurs when a firm does not perform at least one identity test on each component of a drug product, and does not validate or establish the reliability of the component supplier’s test analyses at appropriate intervals. The regulation requires that the identity of each component be verified by at least one test, and that supplier test results be validated or periodically verified. To remediate, Stream2Sea, LLC must establish and follow written procedures to conduct identity testing on each component, and implement a supplier qualification program that includes validating or periodically verifying the reliability of supplier test analyses. The firm must document all testing and validation activities.", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stream2sea-llc-718983-02022026", "company": "Stream2Sea, LLC", "issue_date": "02/02/2026"} | |
| {"cfr_code": "21 CFR 211.67(b)", "violation_type": "Equipment Cleaning and Maintenance", "severity_rating": "High", "raw_observation": "Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).", "corrective_action_plan": "Establish and follow adequate written procedures for cleaning and maintenance of equipment. These procedures must specify cleaning and maintenance schedules, methods, equipment, and materials, and must be documented. The firm must ensure that equipment is cleaned and maintained in accordance with these procedures to prevent contamination and ensure product quality.", "synthetic_instruction": "An FDA inspection revealed that Stream2Sea, LLC failed to establish and follow adequate written procedures for cleaning and maintenance of equipment under 21 CFR 211.67(b). What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 211.67(b) occurs when a firm does not have adequate written procedures for cleaning and maintenance of equipment, or fails to follow such procedures. The regulation requires that equipment be cleaned and maintained in accordance with written procedures to prevent contamination and ensure product quality. To remediate, Stream2Sea, LLC must establish and implement written procedures for cleaning and maintenance of equipment, including schedules, methods, and documentation. The firm must also ensure that these procedures are followed and that records of cleaning and maintenance are maintained.", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stream2sea-llc-718983-02022026", "company": "Stream2Sea, LLC", "issue_date": "02/02/2026"} | |
| {"cfr_code": "21 CFR 211.192", "violation_type": "Failure to Investigate Discrepancies", "severity_rating": "Critical", "raw_observation": "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).", "corrective_action_plan": "Establish and implement written procedures for thoroughly investigating any unexplained discrepancy or failure of a batch or any of its components to meet specifications, whether or not the batch has already been distributed. Ensure investigations extend to all potentially affected batches and include root cause analysis, corrective and preventive actions, and documentation of conclusions.", "synthetic_instruction": "An FDA inspection revealed that Bentley Laboratories LLC 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, in violation of 21 CFR 211.192. What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 211.192 occurs when a firm does not thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, regardless of whether the batch has already been distributed. The regulation requires a thorough investigation, extending to all potentially affected batches, with documented conclusions and appropriate corrective actions. To remediate, Bentley Laboratories LLC must establish and implement written procedures that ensure every such discrepancy or failure is thoroughly investigated, root causes are identified, corrective and preventive actions are taken, and the investigation and its conclusions are fully documented.", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bentley-laboratories-llc-732028-09172026", "company": "Bentley Laboratories LLC", "issue_date": "09/17/2026"} | |
| {"cfr_code": "21 CFR 211.84(d)(1) and 211.84(d)(2)", "violation_type": "Component Testing and Supplier Verification", "severity_rating": "Critical", "raw_observation": "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)).", "corrective_action_plan": "Implement procedures to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Additionally, validate and establish the reliability of component supplier’s test analyses at appropriate intervals, and maintain documentation of these activities.", "synthetic_instruction": "An FDA inspection revealed that Bentley Laboratories LLC failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and also failed to validate and establish the reliability of its component supplier’s test analyses at appropriate intervals, in violation of 21 CFR 211.84(d)(1) and 211.84(d)(2). What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 211.84(d)(1) and 211.84(d)(2) occurs when a firm does not test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and does not validate and establish the reliability of the component supplier’s test analyses at appropriate intervals. The regulation requires that components be tested to ensure they meet all written specifications and that supplier test results be periodically validated for reliability. To remediate, Bentley Laboratories LLC must implement and follow written procedures to test each component for identity, purity, strength, and quality, and must validate and establish the reliability of supplier test analyses at appropriate intervals, documenting all testing and validation activities.", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bentley-laboratories-llc-732028-09172026", "company": "Bentley Laboratories LLC", "issue_date": "09/17/2026"} | |
| {"cfr_code": "21 CFR 211.100(a)", "violation_type": "Production and Process Control Procedures", "severity_rating": "High", "raw_observation": "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)).", "corrective_action_plan": "Develop, establish, and implement adequate written procedures for production and process control that are designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess. Ensure these procedures are followed and maintained.", "synthetic_instruction": "An FDA inspection revealed that Bentley Laboratories LLC failed to establish adequate written procedures for production and process control designed to assure that the drug products it manufactures have the identity, strength, quality, and purity they purport or are represented to possess, in violation of 21 CFR 211.100(a). What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 211.100(a) occurs when a firm fails to establish adequate written procedures for production and process control that are designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess. The regulation requires that such written procedures be established and followed. To remediate, Bentley Laboratories LLC must develop, establish, and implement adequate written procedures for production and process control that ensure the identity, strength, quality, and purity of the drug products, and must maintain documentation demonstrating compliance with these procedures.", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bentley-laboratories-llc-732028-09172026", "company": "Bentley Laboratories LLC", "issue_date": "09/17/2026"} | |
| {"cfr_code": "21 CFR 201.5", "violation_type": "Misbranding / Adequate Directions for Use", "severity_rating": "Critical", "raw_observation": "You failed to bear adequate directions for use on the labeling for these drug products that you have introduced into interstate commerce. 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 these products safely for their intended use. Consequently, the labeling for these drugs products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act.", "corrective_action_plan": "Establish and implement a labeling control procedure to ensure that all drug products introduced into interstate commerce bear adequate directions for use as defined in 21 CFR 201.5, or are otherwise exempt from the adequate directions for use requirement. For prescription drugs intended for conditions not amenable to self-diagnosis and treatment by a layperson, cease offering the products for sale to U.S. consumers unless and until the products are approved in the United States or otherwise qualify for an exemption under 21 CFR 201.115(a). Document the labeling review and approval, and maintain records demonstrating compliance.", "synthetic_instruction": "An FDA inspection revealed that Celmade failed to bear adequate directions for use on the labeling for drug products it introduced into interstate commerce, as required under 21 CFR 201.5. What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance: Under 21 CFR 201.5, \"adequate directions for use\" means directions under which a layperson can use a drug safely and for the purposes for which it is intended. Celmade's drug products are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, so adequate directions cannot be written such that a layperson can use these products safely for their intended use. The labeling therefore fails to bear adequate directions for use, and the products are misbranded under section 502(f)(1) of the FD&C Act. Because these drugs are not approved in the United States, they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1). By offering these drugs for sale to U.S. consumers, www.celmade.co and celmade.net are causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act. Remediation: Celmade must ensure that labeling for all drug products introduced into interstate commerce bears adequate directions for use as defined in 21 CFR 201.5, or that the products qualify for an applicable exemption. For prescription drugs intended for conditions not amenable to self-diagnosis and treatment by a layperson, Celmade must cease offering the products for sale to U.S. consumers unless and until the products are approved in the United States or otherwise exempt under 21 CFR 201.115(a). Celmade should implement a labeling control procedure, document the labeling review and approval, and maintain records demonstrating compliance.", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/celmade-735876-09142026", "company": "Celmade", "issue_date": "09/14/2026"} | |
| {"cfr_code": "21 CFR 111.12(b)", "violation_type": "Personnel Qualification", "severity_rating": "High", "raw_observation": "You failed to ensure that each person who is identified to perform quality control operations is qualified to do so, as required by 21 CFR 111.12(b). Specifically, neither your Operations Manager nor your Production Manager, who are performing the responsibilities of quality control, is qualified to do so, as neither is knowledgeable about the applicable requirements.", "corrective_action_plan": "Establish and implement a written procedure to ensure that all personnel performing quality control operations are qualified by education, training, and experience to perform their assigned functions. Document the qualifications of the Operations Manager and Production Manager, provide necessary training on applicable requirements, and maintain training records.", "synthetic_instruction": "An FDA inspection revealed that American Pharma Mfg. Inc. did not ensure that each person identified to perform quality control operations is qualified to do so under 21 CFR 111.12(b). What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?", "ideal_completion": "Non-compliance under 21 CFR 111.12(b) occurs when a firm fails to ensure that each person who is identified to perform quality control operations is qualified to do so. In this observation, American Pharma Mfg. Inc. assigned quality control responsibilities to the Operations Manager and Production Manager, but neither individual was knowledgeable about the applicable requirements, rendering them unqualified. To remediate, the firm must establish and implement a written procedure to ensure that all quality control personnel are qualified by education, training, and experience. Specifically, the firm must document the qualifications of the Operations Manager and Production Manager, provide training on applicable requirements, and maintain records of such training and qualifications.", "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/american-pharma-mfg-inc-728227-08042026", "company": "American Pharma Mfg. Inc.", "issue_date": "08/04/2026"} | |