Findings
1Deviation, CAPA, and investigation
Your firm failed to establish and follow required laboratory control mechanisms. (21 CFR 211.160(a)). You did not adequately validate numerous test methods utilized in drug product testing. According to CAPA-2020-034, of your (b)(4) test methods, approximately 60 test methods were reported as deficient, and 75 test method validation or verification reports were missing. These deficient or potentially unvalidated or unverified test methods continued to be used for the in-…
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). Your firm failed to adequately investigate out-of-specification (OOS) laboratory results and unexplained discrepancies. For example: • Your investigation into cross-contamination of 22 lots of Pain Aid Extra Strength (ESF) tablets with the active…
3Computer system validation
Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your firm did not have adequate oversight and control of its electronic data and software systems. During the inspection, our investigators observed that your analysts ran single injections on high performance liquid chromatography (HPLC) equipment without…
About this record
Extracted automatically from the document US FDA published on 2022-04-12. 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.
