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The FDA issued recent warning letters to manufacturing facilities in India, South Korea, China and the U.S., for a wide range of deficiencies, including inadequate testing. Read More
Indian drugmaker Cadila Healthcare was slapped with an FDA warning letter for serious violations at its injectable drug manufacturing facility in Ahmedabad, including cross-contamination from non-dedicated equipment. Read More
Italian API manufacturer Icrom was hit with a ten-item Form 483 by the FDA for serious quality violations at its facility in Concorezzo, north east of Milan. Read More
Mylan was hit with an FDA warning letter for serious GMP violations at an API manufacturing facility in Andhra Pradesh, India, including improper handling of raw materials. Read More
EU investigators found serious deficiencies in aseptic manufacturing during an inspection of the NCPC Hebei Huamin facility in Shijiazhuang, Hebei province. Read More
The Danish Medicines Agency took action against a violative drugmaker by suspending its authorization to manufacture drugs and intermediates, following an inspection that revealed serious GMP violations. Read More
Incomplete cGMP records, active ingredient testing and quality unit shortcomings prompted the FDA to issue a warning letter to Bingbing Pharmaceuticals, an OTC drugmaker in Hubei, China. Read More
Analytical samples for raw materials, in-process and finished products were sent to the Huxley facility for testing, but there was no documentation of the requests. Read More