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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
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall batches of its drug products due to significant GMP deficiencies. Read More
FDA investigators have cleared Akorn’s facility in Illinois for production, following a re-inspection that confirmed the company corrected several GMP deficiencies. Read More