PharMedium Services LLC has agreed to stop compounding sterile injectable drugs at one of its outsourcing facilities until GMP problems are remedied under the terms of a consent decree filed 22 May by the Department of Justice. The firm has also agreed to independent GMP audits at two sites that will remain in operation. The firm was taken to task in the complaint for not taking microbiological problems and quality problems seriously and not correcting deficiencies even after they were pointed out by FDA inspectors, and for not recalling drugs even after finding out that microorganisms were present in final products. At one if its sites, the quality control unit released purportedly sterile drugs for distribution without first verifying sterility.
A federal complaint alleged that PharMedium violated the Food, Drug and Cosmetic Act by distributing adulterated, misbranded and unapproved...