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The FDA handed Baoying County Fukang a warning letter after the company’s management withheld information from the agency and failed to maintain methods and controls in compliance with GMP standards. 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
Unrestricted access to electronic records and a series of quality control deficiencies resulted in a seven-observation 483 for a specialty drugmaker based in Maryland. 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