Teva Parenteral Medicines, Inc.July 29, 2016

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

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Record Details

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.

Company: Teva Parenteral Medicines, Inc.
Inspection Date: July 29, 2016
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
People: Gregory A. Betz, CSO/Sparky L. Bartes, CSO
Marcus F. Yambot (Senior Consumer Safety Officer )
Virgilio F. Pacio (investigator)
Bichsa T. Tran (investigator)

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ID · 99b91acf-e741-4421-a041-dff87c580e22