Overview
- 2 public-safe observations are available for this inspection.
- 2 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
28 Oct 2024
FDCA 505-1(f)(3)(B)
Failure to comply with REMS Elements to Assure Safe Use (ETASU) B
Cited by Vanessa E Coulter, Tyanna N Hadley
28 Oct 2024
FDCA 505-1(f)(4)
Failure to comply with REMS Implementation System
Cited by Vanessa E Coulter, Tyanna N Hadley
Inspected site
APActelion Pharmaceuticals US Inc.Titusville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 505-1(f)(3)(B) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(4) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 2 observations
The full inspection record, as Atlas holds it, 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