The letter outlines "multiple breaches" of manufacturing practice by contract contact manufacturers used to manufacture Dollar Tree's Assured Brand over-the-counter medicines as well as other drug products sold in Dollar Tree and Family Dollar stores.  In its warning letter to Dollar Tree, the FDA now requests that the company implement a system to ensure that it does not import counterfeit medicines.
"In this case, Dollar Tree has ultimate responsibility for ensuring that it does not sell potentially unsafe medicines and other FDA-regulated products to Americans," he said. "We will remain vigilant in our efforts to protect the American public from companies that compromise Americans' health ̵
In response, Dollar Tree, which operates stores under the Dollar Tree and Family Dollar brands, said it is partnering with the FDA and plans to meet with the agency.
"We are concerned about our customers 'security and have very robust and rigorous testing programs in place to ensure our third-party manufacturers' products are safe," Randy Guiler, Vice President of Investor Relations at Dollar Tree, said in a company statement Thursday.
"Each of the articles referred to in the report are current and non-edible products. As always, we partner with the US Food and Drug Administration (FDA). We plan to meet with the FDA in the near future and expect our plans to meet their requirements in all respects, "the statement states.
The company has 15 working days to respond to the FDA in writing, the warning letter states, and "failure to remedy the violations can lead to legal action without further notice, including, without limitation, seizure and injunction."
The warning letter shows how some of the drugs came from Shanghai Weierya Daily Chemicals Factory and Hangzhou Zhongbo Industrial Company Ltd., whose letter has shown patterns of serious violations of the law, such as not testing raw materials or medicines for pathogens and quality.