Findings
1Quality 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)). Your QU did not provide adequate oversight for the manufacture of your products. For example, you stated that you could not provide records to support the CGMP requirements for the manufacture of drugs, including…
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 reliable original data to support the chromatographic analyses performed on over-the-counter (OTC) drug products and components. For example, our investigators documented multiple examples of fabricated laboratory records. During the…
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 laboratory equipment, used to generate analytical data for finished drug product release and stability testing, lacked restricted access and sufficient controls. Specifically, your firm did not have proper controls in place to prevent the deletion or…
About this record
Extracted automatically from the document US FDA published on 2025-03-18. 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.
