# FDA 483 - Regeneron Pharmaceuticals Inc - Unknown Date

Source: https://www.keypedia.com/records/483/regeneron-pharmaceuticals-inc/44a88309-88ee-461c-a886-71549b687a8c

> FDA 483 for Regeneron Pharmaceuticals Inc on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Regeneron Pharmaceuticals Inc
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Regeneron Pharmaceuticals, Inc.'s drug substance manufacturing facility in Rensselaer, NY, revealed significant deficiencies in contamination control and quality assurance. Observations included inadequate physical segregation of activities posing viral contamination risks, insufficient cleaning verification leading to bioburden contamination, and a high percentage of invalidated release and in-process assays. These findings suggest a need for improved controls to ensure product quality and safety.

## Related Documents

- [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)
- [483 - 2024-03-22](https://www.keypedia.com/records/483/regeneron-pharmaceuticals-inc/42489734-29a2-46d5-96fb-7559354403d0)

## Related Officers

- [Richard Ledwidge, Ph.D., Biologist](https://www.keypedia.com/people/richard-ledwidge-phd-biologist/51161c1e-63da-4f24-bf8b-ecc1398c9dbe)
- [CDR Paul N. Thompson, Investigator](https://www.keypedia.com/people/cdr-paul-n-thompson-investigator/7c0bf160-49f0-4d97-b7aa-f78654fe7511)
- [Reyes Candau-Chacon, Ph.D, Microbiologist](https://www.keypedia.com/people/reyes-candau-chacon-phd-microbiologist/7e93758f-43c6-49cb-bd5d-c240f910802d)
- [J. Paul Kirwan, Ph.D., Staff Fellow](https://www.keypedia.com/people/j-paul-kirwan-phd-staff-fellow/c5c1f40b-e115-48fe-8c47-1ad2fb61823a)

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

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321