Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
24 Jun 2016
21 CFR 211.68(b)
input/output verification
Cited by Carrie A Hughes, Carla J Lundi, Ivis L Negron Torres
24 Jun 2016
21 CFR 211.165(a)
Testing and release for distribution
Cited by Carrie A Hughes, Carla J Lundi, Ivis L Negron Torres
24 Jun 2016
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Carrie A Hughes, Carla J Lundi, Ivis L Negron Torres
Inspected site
RPROIS Phoenix IncPhoenix, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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