CELGENE CORPORATION
Form 483 issued December 6, 2024 · SUMMIT, New Jersey
- Inspection
- Dec 2 – Dec 6, 2024
- Investigator
- Tyanna N. Hadley
- Observations
- 4
- Pages
- 4
- FEI number
- 3004991673
In short: On December 6, 2024, FDA issued a Form 483 with 4 observations to CELGENE CORPORATION in SUMMIT, New Jersey (FEI 3004991673) after an inspection that ran Dec 2 – Dec 6, 2024. The investigator was Tyanna N. Hadley.
What FDA observed
Preview: the opening words of each observation- 01FDCA 505-1(f)(4)
An application holder did not comply with the audit plan and schedule described in the REMS…
- 02FDCA 505-1(f)(3)(E)
EMPLOVEE,S) SGAATURE DATEISSUED An application holder did not instruct healthcare providers or health care facilities to…
- 03FDCA 505-1(f)(3)(A)
An application holder did not make training available to prescribing healthcare providers (HCPs), as required by…
- 04FDCA 505-1(f)(3)(B)
An application holder did not ensure mechanisms are in place that allow pharmacies the ability to…
This inspection in context
Tyanna N. Hadley
3 documents · 2022–2024
Cites 314.80(b) (postmarketing reporting of adverse drug experiences) 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.
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Questions about this 483
What did FDA find at CELGENE CORPORATION?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected CELGENE CORPORATION?
Tyanna N. Hadley is named on this Form 483, for the inspection of Dec 2 – Dec 6, 2024. Each investigator has a profile showing what they cite most.
When was CELGENE CORPORATION inspected by FDA?
The inspection ran Dec 2 – Dec 6, 2024, and the Form 483 is dated December 6, 2024.
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.