FDA 483 - Teva Parenteral Medicines, Inc. - June 04, 2013

An FDA inspection of Teva Parenteral Medicines Inc in Irvine, CA, from May 29 to June 4, 2013, revealed a significant failure to perform thorough investigations into unexplained discrepancies. The firm did not properly identify root causes for issues such as unmaintained equipment (a clean compressed air filter) and the use of a non-validated test method for endotoxin analysis, indicating deficiencies in their quality system and control unit oversight.