Findings
1Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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 (2)). Based on the records and information you provided, you did not demonstrate adequate identity testing of incoming components used to manufacture your drug products, and you accepted test results from suppliers…
2Quality unit oversight
Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)) The records and information you submitted demonstrate that your quality unit (QU) lacks adequate quality oversight over the manufacture and release of finished drug product shipped to the United States. Specifically…
3Laboratory and QC controls
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). Your response to our records request and other information under section 704(a)(4) indicated that you did not conduct adequate finished drug product testing on drug products shipped to the United States…
About this record
Extracted automatically from the document US FDA published on 2021-09-21. 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.
