Regeneron Pharmaceuticals, Inc.
FDA inspection history in Rensselaer, New York, 2010 to 2024
- 5
- Form 483s
Every document, by year
- Form 483
2010: one Form 483; 2015: one Form 483; 2019: one Form 483; 2021: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One Form 483, at Rensselaer, New York.
- 2015One Form 483, at Rensselaer, New York.
- 2019–21Two Form 483s, at Rensselaer, New York.
- 2021The longest 483 on file: 6 observations over 8 pages at Rensselaer, New York.
- 2024One Form 483, at Rensselaer, New York.
Cited most
Across all Regeneron Pharmaceuticals observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.198Complaint files2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.100Written procedures; deviations1
The complete Regeneron Pharmaceuticals file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Rensselaer, New York
Five Form 483s · 2010 to 2024 · 17 observations
Latest: Form 483, Mar 22, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-22 | 483 Form 483 | Rensselaer, New York | 1 | $99 |
| 2021-10-25 | 483 Form 483 | Rensselaer, New York | 6 | $99 |
| 2019-10-18 | 483 Form 483 | Rensselaer, New York | 1 | $99 |
| 2015-04-03 | 483 Form 483 | Rensselaer, New York | 3 | $99 |
| 2010-03-31 | 483 Form 483 | Rensselaer, New York | 6 | $99 |
Investigators on these documents
Guerlain Ulysse (1)Mindy M. Chou (1)Patric C. Klotzbuecher (1)Richard Ledwidge (1)Robert J. Martin (1)Sony Mathews (1)
FEI number 1000514603 · most recent document Mar 22, 2024
About Regeneron Pharmaceuticals, Inc.
How many FDA Form 483s has Regeneron Pharmaceuticals, Inc. received?
FDA Intel has 5 Form 483s on file for Regeneron Pharmaceuticals, Inc.; the most recent is dated Mar 22, 2024.
When was Regeneron Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Regeneron Pharmaceuticals, Inc. is a Form 483 dated Mar 22, 2024, for the site in Rensselaer, New York.
What did FDA cite at Regeneron Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for Regeneron Pharmaceuticals, Inc. are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.198 (Complaint files), 2 times.