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FDA Issues Draft Guidance on Registration and Listing for Cosmetics Required under MOCRA

FDA Law Blog

As reported previously , MOCRA includes a requirement for facility registration and listing of cosmetic products. Specifically, with some exceptions, parties that own or operate a facility engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must list their facilities.

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FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.