Findings
1Laboratory and QC controls
Your firm failed to document at the time of performance required laboratory control mechanisms (21 CFR 211.160(a)). Your laboratory control data was not recorded contemporaneously. Five blank preventative maintenance documents were discovered during the inspection that had been pre-signed and dated to January 9, 2025, in the “Performed by” section. Additionally, your lab manager was observed on August 14, 2025 signing and backdating spectrometry analysis reconciliation…
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). Laboratory Deviations You failed to adequately investigate laboratory deviations. An unofficial audit form was used to document laboratory deficiencies found on July 7, 2025, including a discrepancy in which microbiological sample plates could not be…
3Quality unit oversight
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 quality unit (QU) failed to ensure that all CGMP records were retained and available for review. Our investigator discovered two garbage bags containing torn analytical records, including chromatographic results, unidentified number lists…
About this record
Extracted automatically from the document US FDA published on 2026-03-10. 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.
