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 CFR 211.22). Based on the records and the information you provided, you did not demonstrate that your quality unit (QU) adequately exercises its authority and responsibilities including, but not limited to, implementing effective procedures and conducting…
2Process validation
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 (21 CFR 211.100(a)). Based on the records and information you provided, you did not demonstrate that you have adequately qualified your (b)(4) system. Additionally, you did not demonstrate that you adequately monitor your (b)(4) system…
3Material 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)). Your firm manufactures OTC drug products such as (b)(4) . Based on the records and information you provided, you did not demonstrate that you adequately tested each shipment of each lot of incoming…
About this record
Extracted automatically from the document US FDA published on 2026-06-16. 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.
