Have inspections of all Chinese manufacturing plants that make enoxaparin been consistently conducted by FDA officials?
Yes. FDA inspects both domestic and foreign manufacturing facilities to assess compliance with current good manufacturing practice (CGMP). The CGMP requirements for drugs include requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug. CGMP requirements help to assure the identity, strength, quality, and purity of drugs. The approval process for generic drug marketing applications, including those for generic enoxaparin, includes a review of the manufacturer’s compliance with CGMP. FDA investigators determine whether the firm has the necessary facilities, methods, and controls to manufacture the drugs. Decisions regarding compliance with CGMP regulations are based upon inspection of the facilities, sample analyses, and compliance history of the company. Manufacturers are held to the same standards by FDA to assure the identity, strength, quality, and purity of drugs. 12. Is generic enoxaparin the first product approved in the U.S.
