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Srikem Laboratories, an India-based active pharmaceutical ingredient manufacturer has been hit with a Form 483 after an inspection showed a number of repeat observations. The firm failed to meet established specifications, laboratory control procedures and equipment failures. Read More
FDA investigators handed France-based drug manufacturer Merck Sharp & Dohme-Chibret Laboratories a Form 483 after an inspection revealed sterilization issues and drug batch failures were not reported on time. Read More
The FDA Philadelphia district office has issued a warning letter to a compounding pharmacy in Allentown, PA over misbranded drugs and sterility issues. Read More
The FDA served drug manufacturer Japanese drugmaker Eisai a Form 483 after an inspection of its Baltimore, Maryland facility revealed recordkeeping and quality control issues that led to incomplete data and unrestricted access to computers. Read More
Wockhardt is in hot water with the FDA again, receiving another warning letter for significant GMP violations regarding quality and data controls. Read More
FDA served Porton Biopharma a warning letter after an inspection revealed failures to notify the agency of changes affecting drugs, and failing to follow procedures to prevent microbiological contamination. Read More
The FDA handed warning letters to three drug manufacturers, citing them for GMP violations that range from data integrity deficiencies to sterility control failures. Read More
The FDA has made great strides in conducting international inspections but still remains understaffed, according to the government’s official watchdog, during a time when the agency has begun to inspect more sites overseas than within the U.S. Read More