Findings
1Material 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 perform adequate identity testing of each incoming component lot, such as (b)(4) , used in the manufacture of your OTC drug products. Identity testing of high-risk drug components such as (b)(4) include limit tests in the USP to ensure that the component meets the relevant safety limits for (b)(4) levels, respectively. Because you did…
2Deviation, CAPA, and investigation
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 (b)(4) over-the-counter (OTC) non-sterile drug products, including those labeled for use in (b)(4) . You failed to conduct an adequate investigation in July 2024 when a batch of drug product failed microbiological testing due to…
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 (b)(4) system for rapid microbiological testing of your finished drug products (for example, total counts, objectionable microorganisms) and failed to demonstrate that it was equivalent to or better than United States Pharmacopeia (USP)…
About this record
Extracted automatically from the document US FDA published on 2026-01-06. 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.
