# FDA 483 - TEVA Pharmaceuticals USA, Inc. - November 10, 2022

Source: https://www.globalkeysolutions.net/records/483/teva-pharmaceuticals-usa-inc/b39f48cf-f738-42cb-82d2-23fc9f40a156

> FDA 483 for TEVA Pharmaceuticals USA, Inc. on November 10, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TEVA Pharmaceuticals USA, Inc.
- Inspection Date: 2022-11-10
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: TEVA Pharmaceuticals USA, Inc. in Fairfield, NJ, a finished product manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate cleaning and maintenance of production equipment leading to unknown residue build-up, use of unqualified equipment for various drug products, and failure to record and justify deviations from written production procedures. These issues indicate a lack of control over manufacturing processes and potential risks to drug product quality and purity.

## Related Officers

- [Jogy George](https://www.globalkeysolutions.net/people/jogy-george/00ef0915-66d2-4b34-9b74-d1e08caf2db3)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Drug Investigator](https://www.globalkeysolutions.net/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.globalkeysolutions.net/companies/teva-pharmaceuticals-usa-inc/cbfbde07-cce0-4920-b446-decfedff5d5c

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248