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 investigations lacked sufficient root cause determinations, corrective actions and preventive actions (CAPAs), and assessment of all potentially affected batches. For example, you did not adequately investigate repeated out-of-limit (OOL) results…
2Computer 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 laboratory equipment used to generate analytical data for finished drug product release lacked restricted access and sufficient controls. There was no assurance that your systems had the appropriate controls to prevent data deletion and record…
3Material and supplier control
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm failed to perform identity testing of each component lot used in the production of your over-the-counter drug products, including (b)(4)…
About this record
Extracted automatically from the document US FDA published on 2025-05-20. 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.
