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.
3 Nov 2009
21 CFR 56.110(c)
Method to keep members advised
Cited by Patric C Klotzbuecher, Susan S Jaughn
3 Nov 2009
21 CFR 56.115(a)(6)
Written procedures per 56.108(a) and (b)
Cited by Patric C Klotzbuecher, Susan S Jaughn
Inspected site
PHProvidence Hospital Institutional Review BoardWashington, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.107(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(6) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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