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 contract manufacture over-the-counter (OTC) drug products such as anticavity mouthwash. You failed to conduct an adequate identity test on each…
2Laboratory 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 trustworthy data to support the analyses performed. For example: Our investigators observed original data (e.g., pH test records) discarded in the trash located in your in-process laboratory. A review of the discarded pH test records found…
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) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure: Adequate procedures describing roles and responsibilities of the QU, including the handling of vendor…
About this record
Extracted automatically from the document US FDA published on 2024-12-03. 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.
