Regeneron Pharmaceuticals, Inc.
Form 483 issued March 31, 2010 · Rensselaer, New York
- Inspection
- Mar 23 – Mar 31, 2010
- Observations
- 6
- Pages
- 1
- FEI number
- 1000514603
In short: On March 31, 2010, FDA issued a Form 483 with 6 observations to Regeneron Pharmaceuticals, Inc. in Rensselaer, New York (FEI 1000514603) after an inspection that ran Mar 23 – Mar 31, 2010. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
4 of 6 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×) · 211.198 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Following a number of failing "clean bold validation studies" for multiple equipmcnts based on bioburdenl endotoxin…
- 02
There are no security measures employed~ the issuance of'worksheets in the raw material testing laboratory located…
- 03
Review of the firm's manual log for SCARs (Supplier Correct ive Action Requests) which was stated…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at Regeneron Pharmaceuticals, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Regeneron Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Mar 23 – Mar 31, 2010, and the Form 483 is dated March 31, 2010.
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.