In its warning letter to Dollar Tree, the FDA outlines a number of corrective actions the company needs to take, including a system to ensure that they do not import impure drugs.
The letter, dated November 6, outlines violations by manufacturers of Dollar Tree's Assured Brand of over-the-counter drugs in Shanghai and other cities.
Donald D. Ashley, director of the office of compliance in the FDA's Center for Drug Evaluation and Research, said Dollar Tree is responsible for ensuring it doesn't sell unsafe drugs.More news: Stone Jury to Begin Deliberations Thursday After Weeklong Trial
The warning letters sent to the contract manufacturers used by Dollar Tree show a pattern of serious violations of the law, such as not testing raw materials or finished drugs for pathogens and quality.
The feds slapped Dollar Tree with a warning this month over the company's imports of potentially risky over-the-counter drugs. And Dollar Tree has also used manufacturers that received warning letters for similar issues since 2016. "We will remain vigilant in our efforts to protect the USA public from companies who put the health of Americans at risk - whether through the manufacturing and distribution of products we regulate or other means".
"All of the products listed by the FDA are "topical, and not ingestible", products", according to the spokesperson, who added that the company intends to work with the agency to resolve the issues.
In a November 6 letter to the retailer, the FDA cited Chinese manufacturers that didn't test products.More news: Ukraine Foreign Minister: U.S. Aid, Investigations Were ‘Never’ Linked
Dollar Tree responded to the FDA memo, saying it is "committed" to righting the situation and complying with regulations.
Dollar Tree is cooperating with the FDA and expects to meet the agency's requirements, said Randy Guiler, the company's vice president of investor relations.
The letter, released Thursday, demands the Virginia-based company put together a plan to make sure it does not import or deliver any more "adulterated" drugs. Reports can be submitted online.More news: Prince Andrew to be quizzed on Epstein in Newsnight special