Findings
1Deviation, 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 did not investigate all unexplained discrepancies and your investigations did not consistently identify root cause(s) or appropriate preventative actions. You also did not consistently conduct investigations in a timely manner to ensure other batches…
2Process validation
Your firm failed to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (21 CFR 211.110(a)). 100% Manual Visual Inspection Your procedures governing the conduct of 100% manual visual inspection of in-process materials and finished drug products lack action levels for significant…
3Process validation
Your firm failed to establish adequate written procedures for production and process control designed to assure that drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all of your written production and process control procedures (21 CFR 211.100(a) and 211.100(b)). Your firm lacked adequate scientific procedures and practices to establish and verify ongoing control of the manufacturing…
About this record
Extracted automatically from the document US FDA published on 2024-08-27. 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.
