Dollar Tree received a warning letter from U.S. regulators for buying over-the-counter drugs from foreign manufacturers that were made in such substandard conditions that they had been barred from entry to the U.S.
The letter sent to Greenbrier International Inc., which does business as Dollar Tree Inc., outlines flaws at facilities in Shanghai and other foreign cities that were detected and flagged by the U.S. Food and Drug Administration between 2017 and 2019. The agency informed the manufacturers and Dollar Tree at the time that the defects made the finished products adulterated drugs. The medicine was produced for Dollar Tree’s Assured Brand label.
Dollar Tree continued to receive the defective products, a violation of the Federal Food, Drug and Cosmetic Act, the agency said in a statement.
The warning letter, dated Nov. 6, comes as drugmakers have increasingly moved their operations abroad to take advantage of lower costs and lesser regulation. The FDA and other regulators have struggled to inspect the burgeoning number of foreign manufacturers, even as questions have arisen over the safety and potential contamination of drugs and OTC products that are increasingly being imported and used by millions of Americans.
“Protecting patient health and safety is our highest priority, and the FDA continues to investigate and take action against companies that place U.S. patients at risk,” said Donald D. Ashley, director of the FDA’s Office of Compliance in its drugs division. “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.”
Dollar Tree said it was cooperating with the FDA and that all of the products identified by the agency are topical, rather than ingestible. The only product mentioned by the FDA that wasn’t redacted was Acne Treatment Pads.
“We are committed to our customers’ safety and have very robust and rigorous testing programs in place to ensure our third-party manufacturers’ products are safe,” said Randy Guiler, a company spokesman, in an email.
The warning letter detailed violations such as failing to test ingredients before or after the products were made to ensure they contained the correct components, not ensuring that they were made to the correct specifications, and not checking for objectionable microorganisms. In another case, rodent feces was found throughout a manufacturing facility where the finished products were made.
No adverse events have been linked to the adulterated products, an agency spokesman said.
While Greenbrier officials told the FDA that they wouldn’t have imported products from an establishment that had been put on an import alert had they been told, the agency disputed the assertion. The company was told to promptly address and correct the violations laid out in the letter and given 15 days to respond to the agency with its action plan.
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