Monday, 28 September 2020 14.00 - 15.30 h
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving potentially unsafe drugs from Chinese suppliers.
The warning letter summarises several violations of current good manufacturing practices (cGMP) at contract manufacturers used to produce over-the-counter (OTC) drugs and cosmetics sold in the companies stores.
The FDA inspected the corporate headquarters, Greenbrier International, Inc. after FDA inspections revealed violative conditions at multiple foreign drug manufacturers that supplied drugs to Greenbrier's distribution network. When analyzing the import data, the FDA found the company bought and received products from foreign companies that had received warning letters and had been placed on import alert for manufacturing issues. Moreover, the FDA noted that Greenbrier has used contract manufacturers and suppliers with histories of significant drug cGMP violations. In this context, it should be noted in particular that the FDA copied Greenbrier's Chief Operating Officer (COO) on several of that outgoing warning letters.
Furthermore, the FDA states in the warning letter that Bureau Veritas (BVS) was contracted to analyze drugs that Greenbrier distributes. Technical lab reports from BVS were used to support the release and distribution of drug products to the United States. When the FDA inspected one BVS location that generated such a technical report, multiple inadequacies related to test methods were found. As BVS could not provide adequate assertion of drug quality according to the FDA, this testing cannot be used as a substitute for testing required.
Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research said in a news release: "Americans expect and deserve drugs that are safe, effective and that meet our standards for quality. The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable.” He also stated that "Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans".
The FDA has requested for the company to implement a system and to provide a detailed plan to ensure that they do not receive or deliver adulterated drugs. Items in that plan should include a full evaluation of the supplier and contract manufacturer evaluation program, including a plan to audit the suppliers. Furthermore, the FDA asked Greenbrier International, Inc., to include a full reconciliation of any drugs from the manufacturers listed in the warning letter, as well as for all firms or drugs currently on FDA import alerts, to determine that there are no remaining drugs in the distribution network or in retail stores.
The company has 15 working days to respond to the FDA in writing. Failure to promptly correct the violations may result in legal action including seizure and injunction.
The original warning letter to Greenbrier International, Inc doing business as Dollar Tree can be found on the FDA website.