Teva Parenteral Medicines, Inc. – FDA 483, Aug 20, 2021

Teva Parenteral Medicines, Inc. received a Form 483 citing significant deficiencies across its manufacturing operations. The firm failed to adequately investigate mold contamination and water leaks, and its aseptic processing validation and environmental monitoring systems were found to be inadequate. These issues, coupled with deficiencies in quality control oversight, data integrity, and sterility testing, indicate a lack of control over critical processes that could impact drug product quality and sterility.