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). Your firm manufactures OTC topical analgesic drug products. Your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, you failed to have written…
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 perform adequate identity testing of each component lot used in the manufacture of your OTC drug products, including for your active ingredient menthol and glycerin. Additionally, you…
3Documentation and records
Your firm 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 211.188). You failed to document the manufacturing instructions for your OTC drug products and did not have any executed batch records for distributed drug products. In your response, you state that, “recipes and procedures have been followed for decades. Though not in writing, they have been…
About this record
Extracted automatically from the document US FDA published on 2025-06-10. 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.
