Regeneron Pharmaceuticals, Inc.
Form 483 issued October 25, 2021 · Rensselaer, New York
- Inspection
- Sep 27 – Oct 25, 2021
- Investigators
- Guerlain Ulysse· Robert J. Martin
- Observations
- 6
- Pages
- 8
- FEI number
- 1000514603
In short: On October 25, 2021, FDA issued a Form 483 with 6 observations to Regeneron Pharmaceuticals, Inc. in Rensselaer, New York (FEI 1000514603) after an inspection that ran Sep 27 – Oct 25, 2021. The investigators were Guerlain Ulysse and Robert J. Martin. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×) · 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmRegeneron Pharmaceuticals, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Regeneron Pharmaceuticals, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Regeneron Pharmaceuticals, Inc.?
Guerlain Ulysse and Robert J. Martin are named on this Form 483, for the inspection of Sep 27 – Oct 25, 2021. Each investigator has a profile showing what they cite most.
When was Regeneron Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Sep 27 – Oct 25, 2021, and the Form 483 is dated October 25, 2021.
How do I get the full Form 483 for Regeneron Pharmaceuticals, Inc.?
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