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August 29, 2019
While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.
August 21, 2019
FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.
August 16, 2019
FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.
August 14, 2019
Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.
August 02, 2019
A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.
Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.
Senior managers of OTC drug companies are on a learning curve, as FDA warning letters cite insufficient understanding of cGMPs and inadequate responses to prior 483s.
August 01, 2019
Performing a compliance gap assessment and focusing on six key factors in your facility’s process definition and controls can help your facility pass its next FDA inspection with flying colors.
July 17, 2019
FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.
July 12, 2019
Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.