We took a snapshot of the 3 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to have correct expiration dates to failing to investigate the unexplained.
From pharmaceuticals in China and India only, here they are (starting with the most recent):
- Hangzhou Facecare Cosmetics Co. Ltd., Hangzhou, China – 3 violations:
- 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)).
- Failed to test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality (21 CFR 211.84(d)(1),(2)).
- Failed to ensure that its drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).
- Hubei Danjiangkou Danao Pharmaceutical Co., Ltd., Danjiangkou, China – 3 violations:
- Failed to demonstrate that manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.
- Failed of quality unit to approve changes that potentially impact API quality.
- Failed to ensure that all test procedures are scientifically sound and appropriate to ensure that API conform to established standards of quality and purity.
- Lupin Limited, Mumbai, India – 2 violations:
- 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).
- Failed to establish appropriate time limits for the completion of each phase of production to assure the quality of the drug product (21 CFR 211.111).
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