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 manufacture topical over-the-counter (OTC) drug products, including (b)(4) labeled for use in (b)(4) . You failed to adequately investigate out-of-specification (OOS) microbiological test results of your drug products. You released batches for…
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 on each shipment of each lot of incoming components (e.g., (b)(4) ) used in the manufacture of your drug products. In addition, you relied on your…
3Laboratory and QC controls
Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)). You failed to adequately validate your alternative rapid microbiological test methods. You use the Neogen Soleris Next Generation System for rapid microbiological testing of your finished drug products (e.g., total aerobic counts, total counts, specified microorganisms) and failed to demonstrate that it was equivalent to or better…
About this record
Extracted automatically from the document US FDA published on 2026-05-05. 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.
