Regeneron Pharmaceuticals, Inc.
Overview
Regeneron Pharmaceuticals, Inc. is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. In collaboration with Sanofi, the company has developed numerous medications targeting a range of conditions.
Therapeutic areas
FDA compliance signals
11 FDA enforcement records linked to this company.
- recall — Class II2024-06-05
Lack of Assurance of Sterility: Complaints of syringe breakage
- recall — Class II2024-05-08
Lack of Assurance of Sterility: Complaints of syringe breakage
- 4832021-10-25
Procedures for sterile drug products
- 4832021-10-25
Validation lacking for sterile drug products
- 4832021-10-25
No written record of investigation
- 4832021-10-25
Cleaning System
- 4832021-10-25
Investigations of discrepancies, failures
- 4832019-10-18
Procedures not in writing, fully followed
- 4832016-08-19
Procedures not in writing, fully followed
- 4832014-06-13
Procedures not in writing, fully followed
- 4832013-05-24
Procedure Deviations Recorded and Justified
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