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What does FDA mean, when it attests to compliance with current Good Manufacturing Practice (cGMP) regulations in an Export Certificate?
FDA performs inspections for compliance with cGMP regulations for drug, biologic, medical devices, human food and animal feed manufacturers that are registered and listed with the Agency. FDA bases its attestation of compliance with cGMP regulations on the manufacturer's most recent FDA inspection and other available information. Generally, FDA cGMP regulations are intended to assure that the manufacturer can manufacture, process, package, and hold a product to assure that it meets the requirements of the Act as to safety, identity, strength, quality, and purity.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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