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A new analysis of state regulatory controls on compounding operations has found significant variance in their oversight and enforcement of traditional compounding operations. Read More
The FDA is urging two Florida compounders to reassess their operations after finding significant issues with GMPs and sterile drug practices during inspections. Read More
Two dietary supplement makers — Puerto Rico-based Majopa Industries and ATS Labs of Houston, Texas — were hit with FDA warning letters over the manufacture of adulterated products. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More
The FDA slammed Denmark’s Novo Nordisk for numerous GMP issues in a 13-item Form 483 for inadequate controls for sterility, environmental monitoring, labeling and written procedures. Read More
The FDA is asking Sun Pharmaceuticals to conduct tests and turn over reams of paperwork in response to a warning letter alleging more than a dozen cGMP violations. Read More
Three stem cell treatment centers have been hit with an FDA warning letter critical of their recordkeeping and lack of required licenses for their clinical procedures. Read More
A December FDA warning letter to China’s Zhejiang Hisun Pharmaceutical outlines the company’s “systemic data manipulation” and cGMP deficiencies uncovered during a March 2015 inspection. Read More