Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-09.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Apr 2026 – 9 Apr 2026 | Biologics | Clean | |
| 26 Oct 2022 – 28 Oct 2022 | Biologics | 483 | View 483 → |
| 12 Apr 2018 – 13 Apr 2018 | Biologics | Clean | |
| 8 Sep 2016 – 9 Sep 2016 | Biologics | Clean | |
| 3 Jun 2014 | Biologics | Clean | |
| 27 Sep 2012 | Not recorded | Clean | |
| 30 Aug 2010 | Not recorded | 483 | View 483 → |
| 9 Jan 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Oct 2022
21 CFR 630.10(g)(2)(ii)
Donor's Acknowledgment - Exculpatory language
Cited by Decarlos A Gomez
28 Oct 2022
21 CFR 630.10(g)(2)(ii)
Donor's Acknowledgment - Exculpatory language
Cited by Decarlos A Gomez
30 Aug 2010
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Anh Lac, Tracy J Washington
Investigators
FDA investigators tied to this site in the record.
Decarlos A Gomez2 insp.
Abby L Mozeke1 insp.
Patty P Kaewussdangkul1 insp.
Amanda J White1 insp.
Young M Yoon1 insp.
Anh Lac1 insp.
Tracy J Washington1 insp.
Karlton T Watson1 insp.
Rhonda L Dash1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 630.10(g)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 630.10(g)(2)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(9) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Carter BloodCare at Hulen's 3 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