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

Source: https://www.keypedia.com/records/483/teva-parenteral-medicines-inc/c0bfa6e1-e202-45f2-a51e-ce981832063d

> FDA 483 for Teva Parenteral Medicines, Inc. on August 30, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teva Parenteral Medicines, Inc.
- Inspection Date: 2019-08-30
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

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## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.keypedia.com/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)
- [SVP Consulting & Operations](https://www.keypedia.com/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)

Company: https://www.keypedia.com/companies/teva-parenteral-medicines-inc/0fca6486-3040-4806-b72d-ff1c31d675c1

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6