Data Integrity Remains Challenging For API Manufacturers
FDA Office Of Compliance Data Highlights Deficiencies
Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.
You may also be interested in...
The good news: 75% of never-before-inspected firms complied with US drug GMP requirements. The bad news: 25% did not.
The FDA's Francis Godwin tells Pink Sheet of progress battling supply chain obfuscation, which could allow marketing of adulterated drugs; Yino warning letter is latest salvo.
Lantech’s solvent recovery operations expected to meet US drug GMP requirements due to risk of carcinogens in blood pressure medications.