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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 firm gave no assurance that samples and batch records from commercial batches it manufactured before the data integrity breach were not impacted. Read More
The FDA has agreed to recognize drug and active pharmaceutical ingredient GMP inspections carried out by authorities in Belgium, Denmark, Finland, Latvia and Estonia, updating the 1998 mutual recognition agreement between the U.S. and the European Union. 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 cited Immunomedics for a host of violations – including its handling of a data integrity breach – observed at its Morris Plains, New Jersey, drug substance manufacturing facility between August 6 and 14. Read More
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