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The FDA hit Vital Laboratories with a Form 483 for incomplete batch production records, inadequate complaint handling and unapproved labeling, among other violations, at its Vapi, Gujarat facility. Read More
The FDA hit Korean drug supplier Barox with a warning letter for quality control, drug labeling and product storage issues at its Seongnam, Gyeonggi facility. Read More
Indian drug manufacturer SkyLark CMC drew a warning letter from the FDA by denying the agency investigator access to its manufacturing facility in Ahmedabad, Gujarat. Read More
The FDA issued a warning letter to Chinese API maker Zhejiang Huahai, the company implicated in a global recall of contaminated valsartan, for failing to adequately investigate the root cause of the NDMA contamination at its Linhai, Taizhou Zhejiang facility. Read More
The FDA withdrew a proposed rule in December that would have allowed generic drugmakers to independently update and distribute revised labeling to reflect new safety data. Read More
The FDA issued final guidance on data integrity and compliance with current good manufacturing practices. Commissioner Scott Gottlieb said the agency revised its recommendations in response to stakeholder requests for more details. Read More
Some of the FDA’s regulatory and compliance activities — including routine inspections — were placed on hold because of the partial government shutdown that began on Dec. 22 and continued into the new year. Read More
The FDA revised its recommendations on current good manufacturing practices for drug compounding outsourcing facilities, drawing a line between agency requirements for sterile and nonsterile drug products and outlining practices to protect against contamination. Read More