FDA Official: Enforcement Crackdown Is Moving Quickly

August 26, 2009
The FDA in the last several months has employed a broad array of tools — a consent decree, drug seizures and 68 warning letters about products to treat influenza A (H1N1) — to accelerate its stricter enforcement campaign. For instance, a June seizure of products from Caraco Pharmaceutical Laboratories occurred six weeks after an FDA inspection, Edwin Rivera-Martinez, chief of the international compliance branch in CDER’s division of manufacturing and compliance, said at the 14th Annual GMP by the Sea conference in Cambridge, Md.
Drug Industry Daily