Findings
1Material 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)). You manufacture over-the-counter (OTC) drug products including (b)(4) . Your firm failed to test incoming components used in manufacturing your…
2Quality 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 QU did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to: Perform assay testing for the strength of the active ingredient in (b)(4) drug products (21 CFR 211.165(b)). Ensure an adequate…
3Laboratory and QC controls
Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Your laboratory records lacked complete and original data to support the analyses performed. For example: Your laboratory records included missing data. Furthermore, there were discrepancies between the original and re-written versions of testing records and COAs pertaining to active…
About this record
Extracted automatically from the document US FDA published on 2025-03-25. 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.
