Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-08-04.
At a glance
Inspections
5
Form 483s
4
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jul 2015 – 4 Aug 2015 | Human Drugs | 483 | On file |
| 24 Apr 2014 – 28 Apr 2014 | Human Drugs | Clean | |
| 17 Apr 2013 – 24 Apr 2013 | Human Drugs | 483 | View 483 → |
| 12 Sep 2012 | Not recorded | 483 | View 483 → |
| 25 Aug 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Apr 2013
21 CFR 314.81(b)(2)(viii)
Post marketing study status report for other studies
Cited by Justine Tomasso
12 Sep 2012
21 CFR 312.50
Ensuring compliance with plan and protocol
Cited by Jonee J Mearns, Krystal O Ogunremi
12 Sep 2012
21 CFR 312.50
General responsibilities of sponsors
Cited by Jonee J Mearns, Krystal O Ogunremi
Investigators
FDA investigators tied to this site in the record.
Frederick Razzaghi1 insp.
Alberto A Viciedo1 insp.
Justine Tomasso1 insp.
Jonee J Mearns1 insp.
Krystal O Ogunremi1 insp.
Dorothy J Denes1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 312.57(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2)(viii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Celgene Corporation's 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat