Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2012-01-13.
At a glance
Inspections
1
Form 483s
1
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jan 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Arthur G Hurst1 insp.
Kathryn A Nagy1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| 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 site report
Get the verbatim findings behind Arnot Health IRB's 1 Form 483
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat