Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-16.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jun 2023 – 16 Jun 2023 | Human Drugs | 483 | On file |
| 11 Sep 2017 – 15 Sep 2017 | Human Drugs | 483 | On file |
| 21 Oct 2013 – 25 Oct 2013 | Human Drugs | Clean | |
| 8 Mar 2012 | Not recorded | Clean | |
| 4 Sep 2009 | Not recorded | Clean | |
| 20 Mar 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Sep 2017
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Nicholas A Violand
Investigators
FDA investigators tied to this site in the record.
Camerson E Moore1 insp.
Nicholas A Violand1 insp.
Cody D Rickman1 insp.
Janet L Bowen1 insp.
Luis M Burgos Medero1 insp.
Marie F Morin1 insp.
Peter C Chow1 insp.
Barry Rothman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Celgene International Sarl's 3 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