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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
The FDA hit CTX Lifesciences with a warning letter for several failures at its India-based drug manufacturing facility and the quality of its active pharmaceutical ingredients. Read More