Teva Parenteral Medicines, Inc.August 30, 2019

FDA 483 - Teva Parenteral Medicines, Inc. - August 30, 2019

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Record Details

Teva Parenteral Manufacturing in Irvine, CA, was cited for multiple deficiencies during an FDA inspection. Key issues include failures in submitting NDA-Field Alert Reports, inadequate investigation of discrepancies and complaints, and insufficient employee training for visual inspection. Additionally, the firm lacked established procedures for preventing microbiological contamination, proper process validation, and adherence to laboratory control mechanisms.

Company: Teva Parenteral Medicines, Inc.
Inspection Date: August 30, 2019
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
People: Alan P. Kurtzberg (Consumer Safety Officer (Drug Specialist))
Linda F. Murphy (SVP Consulting & Operations)

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ID · c0bfa6e1-e202-45f2-a51e-ce981832063d