Overview
- 14 public-safe observations are available for this inspection.
- 13 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.
13 Jan 2012
21 CFR 56.106(e)
Changes in contact or chairperson information
Cited by Arthur G Hurst, Kathryn A Nagy
13 Jan 2012
21 CFR 56.108(a)(1)
Reporting findings and actions to investigator/institution
Cited by Arthur G Hurst, Kathryn A Nagy
13 Jan 2012
21 CFR 56.108(a)(2)
More frequent reviews, verification of no changes
Cited by Arthur G Hurst, Kathryn A Nagy
Inspected site
AHArnot Health IRBElmira, 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 56.106(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.107(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.109(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.109(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.110(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.113 | 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)(4) | 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 14 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