CELGENE CORPORATION
Form 483 issued January 25, 2017 · SUMMIT, New Jersey
- Inspection
- Dec 19, 2016 – Jan 25, 2017
- Investigator
- Melissa T. Roy
- Observations
- 1
- Pages
- 2
- FEI number
- 3004991673
In short: On January 25, 2017, FDA issued a Form 483 with 1 observation to CELGENE CORPORATION in SUMMIT, New Jersey (FEI 3004991673) after an inspection that ran Dec 19, 2016 – Jan 25, 2017. The investigator was Melissa T. Roy. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
This inspection in context
Melissa T. Roy
6 documents · 2016–2018
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New Jersey.
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 314.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CELGENE CORPORATION?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected CELGENE CORPORATION?
Melissa T. Roy is named on this Form 483, for the inspection of Dec 19, 2016 – Jan 25, 2017. Each investigator has a profile showing what they cite most.
When was CELGENE CORPORATION inspected by FDA?
The inspection ran Dec 19, 2016 – Jan 25, 2017, and the Form 483 is dated January 25, 2017.
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.