19 Nov 2019
U.S. Retailer Warned for Selling Adulterated Drugs Made in Mainland China
The Food and Drug Administration has issued a warning letter to a large U.S. retailer for receiving over-the-counter drugs produced by foreign manufacturers, including several mainland Chinese manufacturers, found to have serious violations of federal law. According to a FDA press release, the letter outlines, among other things, multiple violations of current good manufacturing practices at contract manufacturers used to produce OTC drugs for the retailer.
The letter details how the retailer received adulterated drugs from manufacturers that received FDA warning letters in 2018 as well as the retailer’s use of contract manufacturers that also received warning letters for similar issues between 2016 and 2019. Violations included not testing raw materials or finished drugs for pathogens and quality. Manufacturers that received these warning letters were placed on import alert, which are used to prevent potentially violative products from being imported into the U.S. market. The FDA notified the retailer of warning letters sent to the non-compliant manufacturers at the time such letters were sent.
The warning letter sent to the retailer outlines the corrective actions that must be taken, including the implementation of a system to prevent further imports of adulterated drugs.