Intending to close the frequency gap between foreign and domestic inspections, FDA has been increasing its foreign inspections, especially at drug plants in India. India is FDA’s current top priority, as it has the largest number of drug manufacturers and is a major source of generic drugs, both brought into the U.S. and globally. In 2013, many Indian drug manufacturers failed FDA’s surprise facility inspections.
FDA discovered a host of cGMP violations, including lack of adequate documentation, lack of quality control procedures, failure to investigate, correct and prevent manufacturing problems, incomplete records of testing, and many others. FDA placed the offending firms on Import Alert immediately, and increased its scrutiny of Indian drug facilities. That scrutiny paid off for the Agency, as it discovered serious cGMP violations at a large number of plants, and consequently issued more warning letters to Indian drug firms in a four-month period than it had in the previous three years.
About 8 in 10 of the prescriptions filled in the U.S. are for generic drugs, and there is a growing trend for both generic and branded drugs manufactured overseas. cGMP compliance is the primary regulatory method to ensure drug safety, and quality for U.S. consumers, especially at those foreign facilities where FDA oversight is weak. Any document falsification or failure to follow procedure can, at best, undermine the efficacy of a drug, and at worst adulterate the drug – potentially causing life-threatening effects.
What does this mean for importers? Failure to comply with FDA’s drug cGMPs renders the imported drugs adulterated under FDCA and can result in FDA import detention and refusals on the border. At worst, FDA will place the foreign drug manufacturer on an FDA Import Alert. In other words, every shipment from that manufacturer will be automatically detained until the compliance problems are resolved.
FDAImports.com specializes in applying FDA’s drug GMP regulation requirements for drug industry members. We can assist with audits of drug manufacturing facilities to ensure success in pending FDA inspections. Contact us today for further information.
