Regeneron Pharmaceuticals, Inc.
Form 483 issued October 18, 2019 · Rensselaer, New York
- Inspection
- Oct 9 – Oct 18, 2019
- Investigators
- Mindy M. Chou· Patric C. Klotzbuecher· Sony Mathews
- Observations
- 1
- Pages
- 4
- FEI number
- 1000514603
In short: On October 18, 2019, FDA issued a Form 483 with 1 observation to Regeneron Pharmaceuticals, Inc. in Rensselaer, New York (FEI 1000514603) after an inspection that ran Oct 9 – Oct 18, 2019. The investigators were Mindy M. Chou, Patric C. Klotzbuecher and Sony Mathews. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Regeneron Pharmaceuticals, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Regeneron Pharmaceuticals, Inc.?
Mindy M. Chou, Patric C. Klotzbuecher and Sony Mathews are named on this Form 483, for the inspection of Oct 9 – Oct 18, 2019. Each investigator has a profile showing what they cite most.
When was Regeneron Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Oct 9 – Oct 18, 2019, and the Form 483 is dated October 18, 2019.
How do I get the full Form 483 for Regeneron Pharmaceuticals, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.