Overview
- 6 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
3 Sep 2009
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Nicholas A Violand, Addam S Reynolds, Dawn L Wydner
3 Sep 2009
21 CFR 314.80(b)
Failure to review ADE information
Cited by Nicholas A Violand, Addam S Reynolds, Dawn L Wydner
3 Sep 2009
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Nicholas A Violand, Addam S Reynolds, Dawn L Wydner
3 Sep 2009
21 CFR 314.80(c)(1)(ii)
Failure to separately submit original and follow-up reports
Cited by Nicholas A Violand, Addam S Reynolds, Dawn L Wydner
3 Sep 2009
21 CFR 314.80(c)(2)
Failure to report non-alert ADEs
Cited by Nicholas A Violand, Addam S Reynolds, Dawn L Wydner
Inspected site
CCCelgene CorporationSummit, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere