Drugs | Good Manufacturing Practices
FDA regulations require that all drugs be manufactured in accordance with FDA’s Good Manufacturing Practice (GMP) regulations. Proper manufacturing of a drug product is as important as proper drug formulation and product drug design. Failure of a manufacturer to comply with FDA’s drug GMPs renders the manufactured drugs adulterated under the Federal Food Drug and Cosmetic Act (FDCA) and FDA regulations. FDA often seizes drugs that were manufactured out of drug GMP compliance.
If FDA determines that a foreign drug manufacturer is failing to comply with FDA’s drug GMPs, the agency will place the foreign drug manufacturer on an FDA Import Alert. Future drug importations from that drug manufacturer will be subject to FDA import detentions and FDA import refusals. This results in FDA blocking and automatically detaining imported drug shipments from that drug manufacturer until the drug GMP compliance problems are solved (and documented for FDA review).
FDAImports.com, LLC’s consultants have extensive expertise and experience in applying FDA’s drug GMP regulation requirements for finished drug manufacturers, sterile drug manufacturing, and API manufacturers. FDAImports.com, LLC can assist with audits of drug manufacturing facilities to ensure pending FDA inspections are successful. FDAImports.com LLC show The Way Through the FDA’s drug GMP regulatory compliance requirements.