CELGENE CORPORATION
Form 483 issued July 18, 2025 · Summit, New Jersey
- Inspection
- Jul 14 – Jul 18, 2025
- Investigators
- Christian Lynch· Massoud Motamed
- Observations
- 6
- Pages
- 7
- FEI number
- 3004991673
In short: On July 18, 2025, FDA issued a Form 483 with 6 observations to CELGENE CORPORATION in Summit, New Jersey (FEI 3004991673) after an inspection that ran Jul 14 – Jul 18, 2025. The investigators were Christian Lynch and Massoud Motamed. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and quality system account for 5 of 6 observations.
Most cited: 21 CFR 211.192 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Written records of investigations into unexplained discrepancies do not include…
This inspection in context
Christian Lynch
4 documents · 2016–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New Hampshire.
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 6 observations on this Form 483, mostly about facilities & equipment, quality system and production. 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?
Christian Lynch and Massoud Motamed are named on this Form 483, for the inspection of Jul 14 – Jul 18, 2025. Each investigator has a profile showing what they cite most.
When was CELGENE CORPORATION inspected by FDA?
The inspection ran Jul 14 – Jul 18, 2025, and the Form 483 is dated July 18, 2025.
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.