The company has fifteen working days to respond to the FDA in writing, and the FDA's letter to The Dollar Tree warned that "failure to promptly correct the violations may result in legal action without further notice including, without limitation seizure and injunction".
The manufacturers had received their own FDA warning letters in recent years and were also placed on import alert, a measure meant to stop the flow of sketchy products into the U.S., federal officials say.
Dollar Tree is selling "potentially unsafe drugs" and cosmetics at its more than 15,000 discount stores, according to federal regulators.
The FDA is requiring Dollar Tree to implement a system to ensure its drugs are safe. The company insisted to the agency that its policy was to stop buying products from a supplier or contract manufacturer if it knew it had received a warning letter or was put on import alert.
The contract manufacturers used by Dollar Tree to make the OTC drugs have received warning letters from the FDA for violations such as not testing raw materials or finished drugs for pathogens and quality.
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"The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable", said Donald D. Ashley, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. The FDA says Dollar Tree was informed about these warning letters at the time they were sent.
"We will remain vigilant in our efforts to protect the USA public form companies who put the health of Americans at risk - whether through manufacturing and distribution of products we regulate or other means", Ashley said. But the FDA delineated cases in which Greenbrier still received products from the CMOs after the agency had copied its chief operating officer on the warning letters that were issued.
The executive said in the statement Dollar Tree is committed to customer safety and plans to meet with the FDA soon.
The company operates almost 15,000 stores under the names Dollar Tree, Family Dollar and Dollar Tree Canada in 48 USA states and five Canadian provinces.