Overview
- 7 public-safe observations are available for this inspection.
- 6 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.
4 Dec 2009
21 CFR 56.108(a)(1)
Reporting findings and actions to investigator/institution
Cited by Michelle M Noe, Leo B Zadecky
4 Dec 2009
21 CFR 56.108(b)(2)
Prompt reporting of noncompliance
Cited by Michelle M Noe, Leo B Zadecky
4 Dec 2009
21 CFR 56.108(b)(3)
Reporting of suspension/termination
Cited by Michelle M Noe, Leo B Zadecky
Inspected site
UOUniversity of Massachusetts Chan Medical School IRBWorcester, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.108(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 56.108(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(b)(3) | 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)(5) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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