FDA Sends Warning Letter to Dollar Tree for Selling Drugs Manufactured by Companies With a History of U.S. Law Violation

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The FDA has slammed Dollar Tree with a warning letter after it found that it had been selling over-the-counter (OTC) drugs made by foreign companies that have violated United States federal law.

In the warning letter sent to Dollar Tree by the FDA on Thursday, the federal agency alleged that Dollar Tree stocked over-the-counter drugs made by Chinese companies that have violated U.S. federal law on goods manufacturing practices. These foreign companies according to the FDA had been issued warning letters in the past and were placed on import alert for issues relating to their manufacturing practices. When the FDA analyzed import data, they discovered that Dollar Tree had bought and received products from these companies.

The Agency has also said that the contract manufacturers and suppliers that Greenbrier Inc. operating as Dollar Tree uses to produce its private-label Assured Brand drugs are guilty of significant violations. In a statement issued by Donald Ashley, the compliance director in the Center for Drug Evaluation and Research said that it is Dollar Tree’s responsibility to make sure that it does not sell potentially harmful drugs and other products regulated by the FDA to Americans.

Earlier this year, the FDA said it did an inspection of Greenbrier’s headquarters and its distribution warehouse after it found out that many foreign companies who supplied drugs to the retailer had violated federal laws. The agency said that one of the companies that Greenbrier worked with was issued a warning letter and placed on import alert in 2017. The company at the time failed to test finished drug products before distribution and the authorities found rodent feces everywhere in the manufacturing facility when it went for inspection.

Responding to the warning letter issued by the FDA, Dollar Tree’s vice president of investor relations, Randy Guiler, said in a statement: “We are committed to the safety of our clients and have very comprehensive testing programs in place to ensure that all products made by our third-party manufacturers are safe for use.” He added that the company is cooperating with the Food and Drug Administration.

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