Overview
- 19 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-22.
At a glance
Inspections
19
Form 483s
9
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Mar 2024 – 22 Mar 2024 | Human Drugs | 483 | On file |
| 27 Sep 2021 – 25 Oct 2021 | Human Drugs | 483 | View 483 → |
| 4 Nov 2019 – 8 Nov 2019 | Human Drugs | Clean | |
| 9 Oct 2019 – 18 Oct 2019 | Human Drugs | 483 | View 483 → |
| 4 Jun 2018 – 8 Jun 2018 | Human Drugs | Clean | |
| 2 Oct 2017 – 5 Oct 2017 | Human Drugs | Clean | |
| 31 Oct 2016 – 4 Nov 2016 | Human Drugs | Clean | |
| 15 Aug 2016 – 19 Aug 2016 | Human Drugs | 483 | View 483 → |
| 1 Feb 2016 – 5 Feb 2016 | Human Drugs | Clean | |
| 30 Mar 2015 – 3 Apr 2015 | Human Drugs | 483 | On file |
| 9 Jun 2014 – 13 Jun 2014 | Human Drugs | 483 | View 483 → |
| 21 May 2013 – 24 May 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Oct 2021
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Guerlain Ulysse, Robert J Martin
25 Oct 2021
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Guerlain Ulysse, Robert J Martin
25 Oct 2021
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Guerlain Ulysse, Robert J Martin
25 Oct 2021
21 CFR 211.192
No written record of investigation
Cited by Guerlain Ulysse, Robert J Martin
Investigators
FDA investigators tied to this site in the record.
Robert C Horan5 insp.
Chad N Thompson2 insp.
Bijoy Panicker1 insp.
Ogechi C Nna1 insp.
Guerlain Ulysse1 insp.
Robert J Martin1 insp.
Thuy T Nguyen1 insp.
Sony Mathews1 insp.
Patric C Klotzbuecher1 insp.
Mindy M Chou1 insp.
Maxwell L Van Tassell1 insp.
Rajiv R Srivastava1 insp.
Wayne E Seifert1 insp.
Maria J Lopez- Barragan1 insp.
Laura Fontan1 insp.
Candace Y Gomez-Broughton1 insp.
Reyes Candau-Chacon1 insp.
Charisse K Green1 insp.
Paul C Mouris1 insp.
Kalavati C Suvarna1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.14(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Regeneron Pharmaceuticals, Inc.'s 9 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat