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The FDA came down on API manufacturer Hanmi Fine Chemicals for cleaning validation and data control violations observed at its Gyeonggi-do, Korea plant. Read More
The FDA hit Hybrid Pharma with a warning letter, citing the Deerfield Beach, Florida, pharmacy for producing drugs that failed to qualify for exemptions from FDA oversight for compounded drugs. 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 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