Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-09-14.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Sep 2023 – 14 Sep 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Aug 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Sep 2023
21 CFR 50.52
Factors required for approval
Cited by Dana M Klimavicz, Christopher M Jeffers
14 Sep 2023
21 CFR 56.108(b)(2)
Prompt reporting of noncompliance
Cited by Dana M Klimavicz, Christopher M Jeffers
14 Sep 2023
21 CFR 56.115(a)(2)
Minutes of IRB meetings
Cited by Dana M Klimavicz, Christopher M Jeffers
Investigators
FDA investigators tied to this site in the record.
Dana M Klimavicz2 insp.
Christopher M Jeffers1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 50.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Baton Rouge General Medical Center IRB's 1 Form 483
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