Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-04-15.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Apr 2026 | Biologics | Clean | |
| 15 Mar 2022 | Biologics | Clean | |
| 2 Nov 2017 | Biologics | Clean | |
| 26 Nov 2014 – 28 Nov 2014 | Biologics | 483 | View 483 → |
| 13 Dec 2012 | Not recorded | Clean | |
| 14 Oct 2011 | Not recorded | Clean | |
| 20 Oct 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Peter S Kessler2 insp.
Alexander M Kay2 insp.
Kaarin M Slotte1 insp.
Sarah J Cullen1 insp.
Dianna D Wardlow-Dotter1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bloodworks' 1 Form 483
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