Quality

Drugmaker Cited for GMP, Quality Issues

A PET finished dose manufacturer in Ohio was cited by the FDA after investigators witnessed numerous cGMP violations and potential quality problems on a January 2014 site visit. Read More

Indiana Compounders Indicted on Conspiracy, Drug Quality

The owner and compliance director of Pharmakon Pharmaceuticals routinely sent drugs to hospitals without waiting for test results confirming the potency of the drugs matched their labels, and when results showed the strength was often nearly double what it should have been, covered up the error and lied to FDA investigators rather than notifying the FDA or customers, according to a 10-count federal indictment. Read More