Overview
- 10 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-16.
At a glance
Inspections
10
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 May 2024 – 16 May 2024 | Biologics | Clean | |
| 3 Mar 2020 – 5 Mar 2020 | Biologics | Clean | |
| 6 Apr 2018 – 12 Apr 2018 | Biologics | Clean | |
| 18 Apr 2016 – 26 Apr 2016 | Biologics | 483 | View 483 → |
| 27 Jan 2014 – 6 Feb 2014 | Biologics | 483 | View 483 → |
| 6 Jun 2012 | Not recorded | 483 | View 483 → |
| 14 Sep 2011 | Not recorded | 483 | View 483 → |
| 15 Mar 2011 | Not recorded | 483 | View 483 → |
| 22 Jan 2009 | Not recorded | Clean | |
| 5 Dec 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Apr 2016
21 CFR 606.171
Biological product deviation report
Cited by Dawn C Olenjack, Dustin K Hampton
6 Feb 2014
21 CFR 606.20(b)
Qualifications of responsible personnel
Cited by Karen M Montgomery, Kathleen B Swat
6 Feb 2014
21 CFR 606.100(b)(13)
Procedures to relate blood from donor to final disposition
Cited by Karen M Montgomery, Kathleen B Swat
6 Feb 2014
21 CFR 606.171
Biological product deviation report
Cited by Karen M Montgomery, Kathleen B Swat
Investigators
FDA investigators tied to this site in the record.
Kathleen B Swat4 insp.
John A Iwen2 insp.
Esther A Ofori1 insp.
Dawn C Olenjack1 insp.
Dustin K Hampton1 insp.
Karen M Montgomery1 insp.
William C Corley1 insp.
Thuy T Nguyen1 insp.
James D Planchon1 insp.
Jeffery L Sumter1 insp.
Brian R Cronenwett1 insp.
Pamela L Vega1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 600.10(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.100(b)(13) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.25(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Barnes-Jewish Hospital Blood Bank's 5 Form 483s
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