The Food and Drug Administration (FDA) issued a warning to Dollar Tree for selling drugs made by manufacturers that failed to test products and, in one case, clean rat feces throughout the facility.
The November 6 letter identified several Chinese suppliers that, between 2016 and 2019, helped make Dollar Tree’s Assured Brand over-the-counter medication and other products sold at store locations.
Drug security isn’t a problem exclusive to Dollar Tree. In recent months, Congress has grown increasingly wary of American regulators’ ability to keep tabs on foreign companies, which produce the majority of active ingredients for generic drugs sold in the United States.
At a hearing last month, lawmakers were shocked to learn the FDA often fails to anticipate tainted drugs until months after they’ve been shipped, distributed and sold to consumers.
Still, while FDA officials can’t require Chinese facilities to produce real-time data on their drug making, they can physically inspect the sites. Such visits recently revealed a pattern of “serious violations,” according to a Thursday press release from the agency.
“The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable,” said Donald Ashley, director of compliance in the FDA’s drug evaluation wing, in a statement. “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 doesn’t make its drugs in-house but rather contracts with China’s Shanghai Weierya Daily Chemicals Factory, Bicooya Cosmetics Limited, Ningbo Pulisi Daily Chemical Products Co. and others. All were guilty of failing to test either raw materials or finished products for contamination.
Investigators found “rodent feces” throughout the factory at Bicooya Cosmetics.
In light of these suppliers’ violations, the FDA asked Dollar Tree for a detailed plan to ensure it doesn’t sell or deliver unsafe drugs.
The plan should include a full evaluation of its supplier and contract manufacturer programs, including a plan to audit its suppliers, according to the FDA. Regulators also asked that Dollar Tree evaluate any drugs from the manufacturers in question, even though they’ve already been placed on import alerts.
“Protecting patient health and safety is our highest priority,” Ashley said, “and the FDA continues to investigate and take action against companies that place U.S. patients at risk. Americans expect and deserve drugs that are safe, effective and that meet our standards for quality.”
Dollar Tree did not immediately respond to a request for comment.
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