# FDA 483 - Teva Parenteral Medicines, Inc. - January 18, 2019

Source: https://www.keypedia.com/records/483/teva-parenteral-medicines-inc/dc6743ea-2a3e-415d-8ebd-114d581bd7f9

> FDA 483 for Teva Parenteral Medicines, Inc. on January 18, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Teva Parenteral Medicines, Inc.
- Inspection Date: 2019-01-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Fera Parenteral Manufacturing in Irvine, CA, revealed significant deficiencies across multiple areas. The firm lacked adequate written procedures for production and process controls, failed to follow established procedures, and exhibited poor laboratory control mechanisms. Additionally, the accuracy, specificity, and reproducibility of test methods for drug products were not properly established.

## Related Documents

- [483 - 2009-07-24](https://www.keypedia.com/records/483/teva-parenteral-medicines-inc/823311f0-8e08-4dd3-afe8-5e78fdadf779)
- [483 - 2021-08-20](https://www.keypedia.com/records/483/teva-parenteral-medicines-inc/b639b463-9013-4135-a37d-81c31801d356)
- [EIR - 2010-05-14](https://www.keypedia.com/records/eir/teva-parenteral-medicines-inc/6a358c56-b202-4ff2-beac-e0b9413decf7)
- [EIR - 2012-04-24](https://www.keypedia.com/records/eir/teva-parenteral-medicines-inc/b299d610-ae8c-472a-874f-b86459f675d6)
- [483 - 2013-06-04](https://www.keypedia.com/records/483/teva-parenteral-medicines-inc/a341f217-c45e-4025-8a02-d53234f20847)

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/adam-r-cooke/337c005d-e9dc-4512-aadb-ee0b0c637bd5)
- [investigator](https://www.keypedia.com/people/amanda-l-fyles/4a00278a-a7c5-4751-a8b7-6c0ce2e24272)
- [investigator](https://www.keypedia.com/people/amir-alavi/d7179128-eb3f-489e-97cf-e2c5e5539a00)

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