# Regeneron Pharmaceuticals Inc – FDA 483, Oct 18, 2019

Source: https://www.keypedia.com/records/483/regeneron-pharmaceuticals-inc/cdc34046-95b0-4b53-851f-dfbbdefa15ff

> FDA 483 for Regeneron Pharmaceuticals Inc on October 18, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Regeneron Pharmaceuticals Inc
- Inspection Date: 2019-10-18
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Regeneron Pharmaceuticals Inc, a biological drug substance manufacturer in Rensselaer, NY, was inspected from October 9-18, 2019. The inspection revealed that the firm's quality control unit failed to fully follow its responsibilities and procedures, specifically by not assessing unexpected events that could affect product safety, purity, or potency for regulatory reporting. This indicates a significant lapse in the firm's quality system regarding deviation management and regulatory compliance.

## Related Documents

- [483 - 2024-03-22](https://www.keypedia.com/records/483/regeneron-pharmaceuticals-inc/42489734-29a2-46d5-96fb-7559354403d0) — date: March 22, 2024
- [483 - 2021-10-25](https://www.keypedia.com/records/483/regeneron-pharmaceuticals-inc/5edf66c0-5435-47f5-8b9c-95bb5b5aa87c) — date: October 25, 2021
- [EIR - 2019-10-18](https://www.keypedia.com/records/eir/regeneron-pharmaceuticals-inc/2f21fa9c-603b-4c48-adf9-570ec85676b9) — date: October 18, 2019
- [EIR - 2018-06-08](https://www.keypedia.com/records/eir/regeneron-pharmaceuticals-inc/81a20693-7265-4381-9e44-5d937815704f) — date: June 8, 2018
- [483](https://www.keypedia.com/records/483/regeneron-pharmaceuticals-inc/44a88309-88ee-461c-a886-71549b687a8c)

## Related Officers

- [Consumer Safety Officer Drug Specialist](https://www.keypedia.com/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)
- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [Patric C. Klotzbuecher](https://www.keypedia.com/people/patric-c-klotzbuecher/cbb2e6b5-b001-457e-9073-33535f02926e)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961