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 aerosol drug products as well as cosmetic products for numerous customers using shared equipment. Your firm failed to perform adequate investigations into benzene contamination in your drug products…
2Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). You failed to adequately test the incoming components used to manufacture your drug products. Specifically, your component identity testing does not include a limit test for diethylene glycol (DEG) and ethylene glycol (EG) on all lots of glycerin before use in the manufacture or preparation of drug products. You manufacture multiple drug products…
3Laboratory and QC controls
Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)). You failed to test many of your topical drug products for critical microbiological attributes. Without testing each batch prior to release, you did not have scientific evidence that all drug product batches were free of microbial contamination that is objectionable in view of its intended use. In…
About this record
Extracted automatically from the document US FDA published on 2023-04-25. 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.
