Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-08-12.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Aug 2022 – 12 Aug 2022 | Medical Devices & Rad Health | Clean | |
| 27 Jan 2016 – 19 Feb 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 May 2011 | Not recorded | 483 | View 483 → |
| 21 May 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Feb 2016
21 CFR 56.108(b)(2)
Prompt reporting of noncompliance
Cited by Erma Zaimova, Andrace Deyampert
4 May 2011
21 CFR 56.108(a)(1)
Initial and continuing reviews
Cited by Sherri J Jackson, Laureen F Kononen
Investigators
FDA investigators tied to this site in the record.
Sherri J Jackson2 insp.
Laureen F Kononen2 insp.
Denise L Burosh1 insp.
Jennifer A Kemp1 insp.
Erma Zaimova1 insp.
Andrace Deyampert1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.115(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 56.108(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.113 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind William Beaumont Hospital IRB's 3 Form 483s
Source PDFs, 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