CELGENE CORPORATION
FDA inspection history across 2 sites, 2010 to 2025
- 7
- Form 483s
Every document, by year
- Form 483
2010: one Form 483; 2012: one Form 483; 2017: one Form 483; 2021: one Form 483; 2023: one Form 483; 2024: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010–12Two Form 483s, at SUMMIT, New Jersey.
- 2017One Form 483, at SUMMIT, New Jersey.
- 2021–25Four Form 483s, at SUMMIT, New Jersey and Summit, New Jersey.
- 2025The longest 483 on file: 6 observations over 7 pages at Summit, New Jersey.
Cited most
Across all CELGENE observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.22Responsibilities of quality control unit2
The complete CELGENE file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
SUMMIT, New Jersey
Six Form 483s · 2010 to 2024 · 18 observations
Latest: Form 483, Dec 6, 2024 →Summit, New Jersey
One Form 483 · 2025 · 6 observations
Latest: Form 483, Jul 18, 2025 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-18 | 483 Form 483 | Summit, New Jersey | 6 | $99 |
| 2024-12-06 | 483 Form 483 | SUMMIT, New Jersey | 4 | $99 |
| 2023-06-16 | 483 Form 483 | SUMMIT, New Jersey | 4 | $99 |
| 2021-02-19 | 483 Form 483 | SUMMIT, New Jersey | 3 | $99 |
| 2017-01-25 | 483 Form 483 | SUMMIT, New Jersey | 1 | $99 |
| 2012-07-30 | 483 Form 483 | SUMMIT, New Jersey | 2 | $99 |
| 2010-03-19 | 483 Form 483 | SUMMIT, New Jersey | 4 | $99 |
Investigators on these documents
Alberto A. Viciedo (1)Christian Lynch (1)Helen B. Ricalde (1)Jose M. Cayuela (1)Justine C. Tomasso (1)Massoud Motamed (1)Melissa T. Roy (1)Tyanna N. Hadley (1)
FEI number 3004991673 · most recent document Jul 18, 2025
About CELGENE CORPORATION
How many FDA Form 483s has CELGENE CORPORATION received?
FDA Intel has 7 Form 483s on file for CELGENE CORPORATION; the most recent is dated Jul 18, 2025.
When was CELGENE CORPORATION last inspected by FDA?
The most recent FDA inspection document on file for CELGENE CORPORATION is a Form 483 dated Jul 18, 2025, for the site in Summit, New Jersey.
What did FDA cite at CELGENE CORPORATION?
The regulations cited most in the observations on file for CELGENE CORPORATION are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 2 times.