Overview
- 9 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-08.
At a glance
Inspections
9
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Apr 2026 – 8 Apr 2026 | Biologics | Clean | |
| 8 Nov 2022 – 9 Nov 2022 | Biologics | Clean | |
| 17 Jul 2019 – 18 Jul 2019 | Biologics | Clean | |
| 26 Aug 2016 | Biologics | Clean | |
| 5 Sep 2014 | Biologics | Clean | |
| 30 Jan 2013 | Not recorded | Clean | |
| 9 Mar 2012 | Not recorded | 483 | View 483 → |
| 26 Oct 2010 | Not recorded | 483 | View 483 → |
| 8 Dec 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Mar 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Dianna D Wardlow-Dotter
26 Oct 2010
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Gloria J Baca, Dianna D Wardlow-Dotter
Investigators
FDA investigators tied to this site in the record.
Peter S Kessler4 insp.
Sunitha K Rajaram2 insp.
Dianna D Wardlow-Dotter2 insp.
Gloria J Baca1 insp.
Kathryn A Krentz1 insp.
Dan G Eisenbrey1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bloodworks' 2 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