FDA WARNING_LETTER - B & J Group - March 14, 2023

The FDA issued a Warning Letter to B & J Group, a manufacturer of OTC drug products, including consumer antiseptic hand rubs, following a review of records submitted in response to a Section 704(a)(4) request. The FDA determined that the company's methods, facilities, or controls for manufacturing, processing, packing, or holding drugs did not conform to Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to test finished drug products:** The firm stated they are a contract filler and did not test finished products for conformance to specifications, identity, or strength before release (21 CFR 211.165(a) and (b)). 2. **Failure to verify component identity:** The firm did not adequately test incoming components, stating raw material identity testing was "Not Applicable" or "Done by customer" (21 CFR 211.84(d)(1)). This is critical given the risks associated with methanol-contaminated ethanol. 3. **Failure to establish written production and process controls:** The firm did not demonstrate reproducible and controlled manufacturing processes, stating batch production records were "Maintained by customers" (21 CFR 211.100(