Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192) Your firm manufactures over-the-counter (OTC) topical drug products for skin and wound care. Your firm failed to adequately investigate several out-of-limit (OOL) and out-of-specification (OOS) laboratory results, as well as unexplained discrepancies. For…
2Material and supplier control
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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 on each shipment of each lot of incoming components (e.g., ethanol, glycerin) used in the manufacture…
3Quality 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 QU failed to perform adequate oversight for the manufacture and testing of your drug products. For example, your QU failed to ensure the following: Performance of annual product reviews (21 CFR 211.180(e)) Performance of adequate testing of…
4Stability and storage
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products, and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). Your firm did not have an adequate stability program to demonstrate that the chemical and microbiological properties of your drug products met established specifications and that they remain acceptable…
About this record
Extracted automatically from the document US FDA published on 2025-11-18. 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.
