Teva Parenteral Medicines, Inc. – FDA 483, Aug 30, 2019

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.