Findings
1Quality 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 CFR211.22). Your quality unit (QU) did not provide adequate oversight for the manufacture of your OTC drug products. In an affidavit dated September 20, 2022, you stated that you could not provide documents related to several CGMP activities such as…
2Material 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 211.84(d)(2)). You failed to test your incoming active pharmaceutical ingredients (APIs) for identity prior to manufacturing your bulk over-the-counter (OTC) drug products, including SPF-50 (b)(4) Sunscreen…
3Documentation and records
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess. Your firm also failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.100 (a) and 21 CFR211.188). Process Validation…
About this record
Extracted automatically from the document US FDA published on 2023-03-21. 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.
