# FDA 483 - Teva Parenteral Medicines, Inc. - August 20, 2021

Source: https://www.globalkeysolutions.net/records/483/teva-parenteral-medicines-inc/b639b463-9013-4135-a37d-81c31801d356

> FDA 483 for Teva Parenteral Medicines, Inc. on August 20, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teva Parenteral Medicines, Inc.
- Inspection Date: 2021-08-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Documents

- [483 - 2009-07-24](https://www.globalkeysolutions.net/records/483/teva-parenteral-medicines-inc/823311f0-8e08-4dd3-afe8-5e78fdadf779)
- [EIR - 2010-05-14](https://www.globalkeysolutions.net/records/eir/teva-parenteral-medicines-inc/6a358c56-b202-4ff2-beac-e0b9413decf7)
- [EIR - 2012-04-24](https://www.globalkeysolutions.net/records/eir/teva-parenteral-medicines-inc/b299d610-ae8c-472a-874f-b86459f675d6)
- [483 - 2016-07-29](https://www.globalkeysolutions.net/records/483/teva-parenteral-medicines-inc/99b91acf-e741-4421-a041-dff87c580e22)
- [483 - 2015-07-10](https://www.globalkeysolutions.net/records/483/teva-parenteral-medicines-inc/497190da-6b42-489c-b17b-7057080cab8a)

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Thomas J. Arista](https://www.globalkeysolutions.net/people/thomas-j-arista/37905892-3285-4f3f-b4b5-f963df1e59d3)
- [Asir Alavi](https://www.globalkeysolutions.net/people/asir-alavi/a7edc110-3309-425f-a771-6f65f4289d12)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)
- [Pharmaceutical investigator](https://www.globalkeysolutions.net/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

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

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