FDA 483 - Teva Parenteral Medicines, Inc. - April 24, 2012

Teva Parenteral Medicines Inc. in Irvine, CA, a sterile drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate environmental and personnel monitoring in aseptic processing areas, and a lack of justification for changes to particle monitoring systems. Additionally, the firm failed to properly maintain equipment, leading to mechanical seal failures and the rejection of multiple lots of Methylprednisolone Injection.