Findings
1Stability and storage
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). Your firm failed to establish an adequate stability program and determine appropriate expiration dates. For example: Your labeled expiration dates are not supported by stability data provided during the…
2Quality unit oversight
You 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 quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example: Multiple drug products that did not meet their specifications were released. Testing for BCC was not performed as required per…
3Deviation, 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 out-of-specification (OOS) results for both drug components and finished drug products. You invalidated microbial OOS results based on limited and inadequate investigations. For example, you tested additional samples…
About this record
Extracted automatically from the document US FDA published on 2022-06-28. 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.
