# FDA 483 - Regeneron Pharmaceuticals Inc - March 22, 2024

Source: https://www.keypedia.com/records/483/regeneron-pharmaceuticals-inc/42489734-29a2-46d5-96fb-7559354403d0

> FDA 483 for Regeneron Pharmaceuticals Inc on March 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Regeneron Pharmaceuticals Inc
- Inspection Date: 2024-03-22
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Regeneron Pharmaceuticals Inc. in Rensselaer, NY, identified a significant deficiency in their quality system. The firm lacked written procedures for production and process controls, specifically concerning a Process Performance Qualification study for drug product formulation. This indicates a failure to ensure drug products consistently meet identity, strength, quality, and purity standards.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/regeneron-pharmaceuticals-inc/44a88309-88ee-461c-a886-71549b687a8c)
- [EIR - 2018-06-08](https://www.keypedia.com/records/eir/regeneron-pharmaceuticals-inc/81a20693-7265-4381-9e44-5d937815704f)
- [483 - 2019-10-18](https://www.keypedia.com/records/483/regeneron-pharmaceuticals-inc/cdc34046-95b0-4b53-851f-dfbbdefa15ff)
- [483 - 2021-10-25](https://www.keypedia.com/records/483/regeneron-pharmaceuticals-inc/5edf66c0-5435-47f5-8b9c-95bb5b5aa87c)

## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Ogechi C. Nna](https://www.keypedia.com/people/ogechi-c-nna/59452184-8197-4ba6-bf1d-78a7e003ef2c)

Company: https://www.keypedia.com/companies/regeneron-pharmaceuticals-inc/cd765cfa-95e6-4023-ade2-0ffa382fe2c7

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