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The FDA handed Chinese manufacturer 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 issued warning letters to two international drug manufacturers for breaching GMP standards by failing to develop procedures to maintain the appropriate quality controls. Read More
Nearly a year after Sun Pharma began implementing a remediation plan to resolve GMP deficiencies at its Halol, India facility, the FDA continues to fault the company for failing to establish and maintain quality controls in a nine-observation Form 483. 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
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. Read More
The European Medicines Agency is reviewing data related to studies performed by Micro Therapeutic Research Labs at two sites in India, following a clinical practice inspection. Read More
Drug manufacturer Warner Chilcott was handed a Form 483 after an inspection revealed inadequate written procedures and deficient cleaning and maintenance of equipment. Read More
The FDA has made great strides in conducting international inspections — but still remains detrimentally 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
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