Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
27 Feb 2025
21 CFR 1.504(d)
Document review entity's hazard analysis
Cited by Devina K Budhan, Devina K Amini
27 Feb 2025
21 CFR 1.506(a)(1)
Approved supplier procedures - importer established
Cited by Devina K Budhan, Devina K Amini
27 Feb 2025
21 CFR 1.506(b)
Supplier verification - establish written procedures
Cited by Devina K Budhan, Devina K Amini
27 Feb 2025
21 CFR 1.506(e)(1)
Verification activity before import, periodically
Cited by Devina K Budhan, Devina K Amini
Inspected site
RURunoland USA, INC.Ridgewood, United States
Inspection team
DKDevina K Amini
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.502(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.504(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(e)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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