Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
6 Dec 2024
FDCA 505-1(f)(3)(A)
Failure to comply with REMS Elements to Assure Safe Use (ETASU) A
Cited by Tyanna N Hadley
6 Dec 2024
FDCA 505-1(f)(3)(B)
Failure to comply with REMS Elements to Assure Safe Use (ETASU) B
Cited by Tyanna N Hadley
6 Dec 2024
FDCA 505-1(f)(3)(E)
Failure to comply with REMS Elements to Assure Safe Use (ETASU) E
Cited by Tyanna N Hadley
Inspected site
CCCelgene CorporationSummit, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 505-1(f)(3)(A) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(3)(B) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(3)(E) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(4) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 4 observations
The source PDF, 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