Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-07-15.
At a glance
Inspections
8
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jul 2026 – 15 Jul 2026 | Biologics | Clean | |
| 7 Dec 2021 | Biologics | Clean | |
| 2 Aug 2016 | Biologics | Clean | |
| 11 Sep 2014 – 12 Sep 2014 | Biologics | Clean | |
| 28 Jan 2013 | Not recorded | Clean | |
| 27 Nov 2012 | Not recorded | 483 | View 483 → |
| 21 Oct 2011 | Not recorded | 483 | View 483 → |
| 21 Oct 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Nov 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Peter S Kessler
27 Nov 2012
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Peter S Kessler
21 Oct 2011
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Dianna D Wardlow-Dotter
21 Oct 2011
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Dianna D Wardlow-Dotter
Investigators
FDA investigators tied to this site in the record.
Peter S Kessler2 insp.
Sunitha K Rajaram1 insp.
Kaarin M Slotte1 insp.
Vanessa Y Jacobs1 insp.
Vanessa Y Gelsey1 insp.
Dianna D Wardlow-Dotter1 insp.
Alexander M Kay1 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(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.60(b) | 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