CELGENE CORPORATION
Form 483 issued July 30, 2012 · SUMMIT, New Jersey
- Inspection
- Jul 16 – Jul 30, 2012
- Investigators
- Jose M. Cayuela· Justine C. Tomasso
- Observations
- 2
- Pages
- 2
- FEI number
- 3004991673
In short: On July 30, 2012, FDA issued a Form 483 with 2 observations to CELGENE CORPORATION in SUMMIT, New Jersey (FEI 3004991673) after an inspection that ran Jul 16 – Jul 30, 2012. The investigators were Jose M. Cayuela and Justine C. Tomasso. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
There is no written testing program designed to assess the stability…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCELGENE CORPORATION history
All 7 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 CELGENE CORPORATION?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. 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 CELGENE CORPORATION?
Jose M. Cayuela and Justine C. Tomasso are named on this Form 483, for the inspection of Jul 16 – Jul 30, 2012. Each investigator has a profile showing what they cite most.
When was CELGENE CORPORATION inspected by FDA?
The inspection ran Jul 16 – Jul 30, 2012, and the Form 483 is dated July 30, 2012.
How do I get the full Form 483 for CELGENE CORPORATION?
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.