FDA WARNING_LETTER - Greenbrier International, Inc - January 18, 2019

The FDA issued a Warning Letter to Greenbrier International, Inc. (Greenbrier), following inspections in January 2019 of its corporate headquarters and Dollar Tree Distribution warehouse. These inspections were prompted by significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Parts 210 and 211) found at multiple foreign drug manufacturers supplying Greenbrier's distribution network. The primary violation identified for Greenbrier was the receipt and delivery of adulterated drugs in interstate commerce, a violation of section 301(c) of the FD&C Act. FDA noted a pattern of Greenbrier using contract manufacturers and suppliers with histories of serious CGMP violations, including those placed on Import Alert 66-40, contradicting Greenbrier's stated policy. Furthermore, Greenbrier's purchasing agreements required suppliers to use Bureau Veritas (BVS) for drug acceptance testing. FDA determined that BVS's test methods were unsuitable for drug CGMP purposes, and its results were inadequate for drug release decisions, meaning Greenbrier relied on testing that could not assure drug quality and was not a substitute for FDA-required testing. Greenbrier must provide a detailed plan within 15 working days to prevent receiving adulterated drugs, including evaluating its supplier program, auditing suppliers, and reconciling all drugs from non-compliant manufacturers. Failure to correct violations may result in legal action, including seizure and injunction.