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). You failed to investigate out-of-specification (OOS) assay results for several lots of your topical over-the-counter (OTC) drug products. For example, assay testing for salicylic acid in your (b)(4) drug product Lot (b)(4) revealed results including…
2Equipment and facility
Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)). You failed to demonstrate that your cleaning and disinfection practices are adequate to remove contaminants from the…
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 failed to appropriately validate your processes and adequately qualify the equipment used to manufacture your topical OTC drug products. Specifically, you have not completed the appropriate process performance…
4Material 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 (2)). You failed to perform an identity test for each component lot used in the production of your drug products, including for the salicylic acid active…
About this record
Extracted automatically from the document US FDA published on 2022-04-12. 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.
