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 released finished drug product Temper Tamer lot# S22-26424D without testing for critical microbial attributes (e.g., total count, absence of objectionable microorganisms). Without testing each batch prior to release, you did not have scientific evidence that all oral drug product batches…
2Deviation, CAPA, and investigation
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). You failed to adequately investigate finished drug product sample results that were out of limit (OOL) for microbiological contamination. For example, you failed to identify a root cause and implement adequate CAPA. You state that you have rejected and…
3Documentation and records
Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your QU did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure: Established procedures were followed (21 CFR 211.22(d)) Batch records were reviewed before drug product release (21 CFR 211.22(a)) Use…
About this record
Extracted automatically from the document US FDA published on 2025-11-18. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
