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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
Critical cleaning steps for equipment such as drug filtration equipment and bottling lines were not recorded in books employees used to log the dates and times of equipment cleaning. 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
For one product, the investigators were “unable to determine quantity of the lot due to the invoice having two different lots with unspecified units.” Read More
Contract drug manufacturer Jubilant HollisterStier drew a Form 483 after the FDA observed contamination risks at the firm’s Kirkland, Quebec facility. Read More