The Food and Drug Administration sent a warning letter to Greenbrier International, Inc. which is doing business as Dollar Tree, for receiving over-the-counter drugs from foreign manufacturers with a pattern of violations of federal law.
The letter outlined violations by the contract manufacturers of Dollar Tree's Assured Brand of OTC drugs.
According to Bloomberg, the letter outlined flaws at facilities in Shanghai as well as other foreign cities which were detected by the FDA between 2017 and 2019. Though this was brought to the attention of both Dollar Tree and the manufacturers, Dollar Tree continued to receive the product, thus violating section 30 I (c) of the Federal Food, Drug and Cosmetic Act (FD&C Act).
The FDA’s warning letter to Dollar Tree detailed the corrective actions and the FDA requested the company implement a system to ensure that they do not import adulterated drugs.
Donald D. Ashley, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, commented on the letter in an FDA news release:
The letter, that was dated Nov 6, gave Greenbrier 15 days to respond to the FDA with a plan to correct violations and prevent it from happening again.
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