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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
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
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
The FDA served Auro Pharmacies — a California-based compounder — with a warning letter after the agency determined the firm produced products under insanitary conditions. Read More