# FDA 483 - Teva Pharmaceuticals USA, Inc - September 29, 2023

Source: https://www.keypedia.com/records/483/teva-pharmaceuticals-usa-inc/5190aa5a-da5d-437b-a8cf-9dce3852e6be

> FDA 483 for Teva Pharmaceuticals USA, Inc on September 29, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teva Pharmaceuticals USA, Inc
- Inspection Date: 2023-09-29
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Teva Pharmaceuticals USA, Inc. in Parsippany, NJ, was cited for failing to maintain adequate drug distribution and dispensing records related to its approved REMS Implementation System. Specifically, the firm did not collect dispensing records from certified inpatient pharmacies. This lapse prevented the company from ensuring restricted distribution of its drug products.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)
- [Mayar M. Mussa](https://www.keypedia.com/people/mayar-m-mussa/4f39b1c8-93a6-4bc9-a800-5f802db48be6)
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Company: https://www.keypedia.com/companies/teva-pharmaceuticals-usa-inc/16ce5163-b7e9-4f34-adce-197945dc8b53

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