Regeneron Pharmaceuticals, Inc.
Form 483 issued April 3, 2015 · Rensselaer, New York
- Inspection
- Mar 30 – Apr 3, 2015
- Investigator
- Richard Ledwidge
- Observations
- 3
- Pages
- 3
- FEI number
- 1000514603
In short: On April 3, 2015, FDA issued a Form 483 with 3 observations to Regeneron Pharmaceuticals, Inc. in Rensselaer, New York (FEI 1000514603) after an inspection that ran Mar 30 – Apr 3, 2015. The investigator was Richard Ledwidge. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Pre and post (b)(4) activities are not physically segregated in Suite Process Area (b)(4). Viral contamination…
- 02
Cleaning verification is not part of the qualification of any (b)(4) resulting…
- 03
A significant number of (b)(4) release and in-process assays were invalidated from May 1, 2013 through…
This inspection in context
Richard Ledwidge
18 documents · 2015–2024
Cites 211.113 (control of microbiological contamination) 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Regeneron Pharmaceuticals, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Regeneron Pharmaceuticals, Inc.?
Richard Ledwidge is named on this Form 483, for the inspection of Mar 30 – Apr 3, 2015. Each investigator has a profile showing what they cite most.
When was Regeneron Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Mar 30 – Apr 3, 2015, and the Form 483 is dated April 3, 2015.
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.