Foreign Manufacturer of Surgical Masks Hit With FDA Warning Letter
The U.S. Food and Drug Administration (FDA) recently issued a warning letter to a manufacturer of surgical masks. The manufacturer, located in Taiwan, was subject to inspection by the FDA that revealed numerous violations of the Federal Food, Drug, and Cosmetic Act (the act). The FDA determined that the masks (medical devices) were adulterated and misbranded under the act. Violations included failure to conform with current good manufacturing practice requirements of the Quality System found at Title 21, Code of Federal Regulations (CFR), Part 820; failure to implement written medical device reporting (MDR) procedures; and failure to have an approved application for premarket approval (PMA) in effect.
To read more, visit Risky Business – Avoiding Product Liability, Commercial, and Other Ligation.