FDA 483 - Teva Parenteral Medicines, Inc. - May 07, 2010

This FDA Form 483 report details significant manufacturing and quality control deficiencies at Teva Parenteral Medicines Inc., many of which are repeat observations from previous inspections. Key issues include inadequate investigations into out-of-specification results and discrepancies, failures in test method validation and instrument calibration, and insufficient written procedures for critical operations like maintenance and quality unit responsibilities. The firm also demonstrated problems with equipment cleaning, WFI system qualification, raw material testing, and timely field alert reporting, impacting various drug products including Propofol Injectable Emulsion and Haloperidol Decanoate Injection.