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The FDA increased its preapproval inspections of generics makers by 60 percent between fiscal years 2011 and 2013, but failed to conduct all of those requested by agency reviewers, a new report finds. Read More
South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches. Read More
The National Institutes of Health is working quickly to correct major lapses in its drug compounding unit so officials will be able to ask the FDA to register it as a cGMP manufacturing facility subject to periodic regulatory inspections. Read More
Compounding pharmacies continue to be plagued by sterility issues, as the FDA handed warning letters to facilities in Florida and Kentucky — bringing to nine the number of compounders cited for such deficiencies since October. Read More
Just as the FDA is ramping up inspections in China, Chinese regulators are increasing their oversight of overseas manufacturing operations, conducting 30 inspections so far in 2015. Read More
The U.S. Food and Drug Administration increased its preapproval inspections of generics makers by 60 percent between fiscal years 2011 and 2013, but failed to conduct all of those requested by agency reviewers, a new report finds. Read More
A slew of observations related to control records, data integrity and manufacturing at Dr. Reddy’s Andhra Pradesh, India, facility resulted in a Form 483. Read More