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 quality unit (QU) failed to perform adequate oversight for the manufacture and testing of your OTC topical drug products. For example, your QU failed to ensure the following: Establishment and review of adequate batch production and control…
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)). Your firm manufactures over-the-counter (OTC) topical drug products, including hand sanitizers, Tincture Green Soap USP, and Isopropyl Alcohol 70% v/v. You failed to adequately perform identity testing…
3Process 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)). You used “ (b)(4) water” as a component to manufacture your OTC topical drug products. However, you have not established that the water system is adequately designed, maintained, and monitored to ensure that it…
About this record
Extracted automatically from the document US FDA published on 2025-07-22. 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.
