Regeneron Pharmaceuticals, Inc.
Form 483 issued March 22, 2024 · Rensselaer, New York
- Inspection
- Mar 13 – Mar 22, 2024
- Observations
- 1
- Pages
- 2
- FEI number
- 1000514603
In short: On March 22, 2024, FDA issued a Form 483 with 1 observation to Regeneron Pharmaceuticals, Inc. in Rensselaer, New York (FEI 1000514603) after an inspection that ran Mar 13 – Mar 22, 2024. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Questions about this 483
What did FDA find at Regeneron Pharmaceuticals, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Regeneron Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Mar 13 – Mar 22, 2024, and the Form 483 is dated March 22, 2024.
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.