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Nippon Fine Chemical impeded a December 2015 inspection, the FDA said in a warning letter that claims employees blocked access to certain areas, refused to provide documents and prevented inspectors from taking photos. Read More
Mappel Industria, a Brazil-based company received a warning letter from the FDA due to significant violations of cGMP regulations for finished pharmaceuticals. Read More
Elite Laboratories has been given a warning letter due to a failure to develop adequate written procedures, particularly for adverse drug experiences (ADEs). Read More
The FDA is looking to increase its post-marketing inspections of manufacturing facilities, mainly within six months to two years after an approval, focused on ensuring that quality is maintained after a company scales up to commercial production. Read More