The FDA spent a week going through records at the headquarters of Greenbrier International, owner of the nearly 16,000 Dollar Tree and Family Dollar stores. What it found was that the company has used some of the world's worst FDA rule offenders to make its Dollar Tree's Assured Brand drugs, including one whose facility was littered with “rodent feces.”
Even after the FDA notified the company that these Chinese contract manufacturers and suppliers had received warning letters, and their products had been banned from the U.S., some of these products still made to the shelves of Dollar Tree, a company that generated $22.8 billion in 2018 sales. The FDA says the problems occurred repeatedly between 2016 and 2019.
After 10 months of back-and-forth about the findings, the FDA has slapped the Chesapeake, Virginia-based company with a warning letter and ordered Greenbrier to a regulatory meeting. In addition, it has demanded that the company develop a plan to solve the problems once and for all.
“Considering that FDA has found a pattern of drug manufacturers with serious CGMP violations in your supply chain, in response to this letter, provide a detailed plan to ensure you do not receive or deliver adulterated drugs,” the FDA said.
The company in a statement insists it already has protections to ensure its products are safe.
“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,” Randy Guiler, Dollar Tree’s vice president of investor relations, said in a statement.
The FDA says the company has told it much the same thing in the past, but that those programs have not always worked. 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. 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.
Not only the FDA says Greenbrier had its contract manufacturers use a testing laboratory that the agency inspected and found used inadequate testing methods. The lab itself acknowledged its test results were not sufficient to determine if products were suitable for release.
“The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable,” Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research said in a statement about the actions. “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.”