FDA 483 - Teva Parenteral Medicines, Inc. - July 29, 2016

An FDA inspection of Teva Parenteral Medicines, Inc. in Irvine, CA, revealed significant deficiencies in their drug manufacturing operations. Observations included unmaintained aseptic processing areas with cracks in barrier shields and inadequate environmental monitoring during critical filling operations. Additionally, the firm failed to ensure proper control procedures for 100% visual inspection of injectable vials, specifically regarding required eye breaks for inspectors.