What happened
FDA states that its March 2026 inspection identified significant CGMP violations in the manufacture of OTC drug products. The firm released U.S.-market batches without finished-product assay testing for the active ingredient, and its quality system did not ensure that required tests were identified, documented, and completed. FDA also observed inadequate identity testing of incoming APIs and raw materials, reliance on supplier certificates of analysis without establishing their reliability, and failure to perform applicable USP monograph tests. Manufacturing processes were not adequately validated: a validated process differed from the batch record, and validation for one product was used to support another product with a different process. Qualification and monitoring of a component used in products and equipment cleaning lacked specified chemical and microbial testing and defined microbial limits. FDA further cited inadequate quality unit oversight, including undocumented process-parameter changes, deficient batch records, and the absence of a written stability testing program. FDA found the firm’s Form FDA 483 response inadequate because it lacked sufficient supporting documentation and evidence of corrective actions.
Why it matters
From a GMP perspective, missing release and incoming-material testing may leave insufficient scientific evidence that products and components meet identity, strength, quality, purity, and safety-related specifications. Inadequate process validation and monitoring can limit assurance that manufacturing remains reproducible and controlled. Undocumented parameter changes and incomplete batch records may impair traceability and evaluation of batch quality. Weak quality unit oversight, supplier controls, and contractual allocation of testing responsibilities can also allow deficiencies to persist across products and batches.
Key topics: OTC batches released without active-ingredient assay testing, Incomplete raw-material identity testing and unverified supplier certificates of analysis, Inadequate process validation and quality unit control of manufacturing changes