Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-06-17.
At a glance
Inspections
5
Form 483s
4
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Jun 2019 – 17 Jun 2019 | Biologics | Clean | |
| 15 May 2017 – 19 Jun 2017 | Human Drugs | 483 | View 483 → |
| 16 May 2016 – 26 May 2016 | Biologics | 483 | View 483 → |
| 4 Sep 2013 – 19 Sep 2013 | Biologics | 483 | View 483 → |
| 15 Jun 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Jun 2017
21 CFR 50.25(a)(6)
Compensation, medical treatment in event of injury
Cited by Sherri N Rohlf
26 May 2016
21 CFR 312.60
FD-1572, protocol compliance
Cited by Sherri N Rohlf, Julian C Hanson, Carla V Jordan
Investigators
FDA investigators tied to this site in the record.
Sherri N Rohlf3 insp.
Julian C Hanson2 insp.
Carla V Jordan1 insp.
James D Hildreth1 insp.
Heika R Tait1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.62(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 312.60 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 312.66 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.55(f) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind James W. Baker, MD's 4 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