The Food and Drug Administration (FDA) has issued a warning letter to Greenbrier International for receiving over-the-counter (OTC) drugs produced by foreign manufacturers with multiple violations of current good manufacturing practices (CGMP). These contract manufacturers produced Dollar Tree’s Assured Brand OTC drugs, among other drug products sold at Dollar Tree and Family Dollar stores.
The warning letter describes Dollar Tree’s receipt of adulterated drugs from manufacturers that received FDA warning letters in 2018. It also describes how the Company used contract manufacturers who were flagged for similar issues between 2016 and 2019. Violations cited at these facilities include, “not testing raw materials prior to use in drug manufacturing and not testing finished drug products prior to distribution.” The FDA has placed these manufacturers on import alert to prevent potentially violative products from entering the US.
As a result, the Agency has requested corrective actions be taken by Greenbrier that include implementation of a system to ensure that adulterated drugs are no longer imported. The Company will have 15 working days to respond with how they plan to correct the violations; failure to do so could result in legal action.
“In this case, Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans. We will remain vigilant in our efforts to protect the US public from companies who put the health of Americans at risk – whether through the manufacturing and distribution of products we regulate or other means,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
Adverse events related to Dollar Tree products should be reported to the FDA’s MedWatch Adverse Event Reporting program.
For more information visit fda.gov.