Overview
- 10 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-10.
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 |
|---|---|---|---|
| 6 Jun 2024 – 10 Jun 2024 | Biologics | Clean | |
| 25 Mar 2019 – 2 Apr 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Aug 2016 – 12 Aug 2016 | Biologics | 483 | View 483 → |
| 12 Nov 2013 – 16 Dec 2013 | Biologics | 483 | View 483 → |
| 14 Dec 2012 | Not recorded | 483 | View 483 → |
| 19 Dec 2011 | Not recorded | 483 | View 483 → |
| 5 Jul 2007 | Not recorded | Clean | |
| 12 May 2004 | Not recorded | Clean | |
| 5 Jun 2003 | Not recorded | Clean | |
| 30 Nov 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Apr 2019
21 CFR 803.17
Lack of Written MDR Procedures
Cited by Kip J Hanks, Cody D Rickman, Dianiris C Ayala
2 Apr 2019
21 CFR 803.17
Lack of Written MDR Procedures
Cited by Kip J Hanks, Cody D Rickman, Dianiris C Ayala
2 Apr 2019
21 CFR 803.17
Lack of Written MDR Procedures
Cited by Kip J Hanks, Cody D Rickman, Dianiris C Ayala
2 Apr 2019
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Kip J Hanks, Cody D Rickman, Dianiris C Ayala
2 Apr 2019
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Kip J Hanks, Cody D Rickman, Dianiris C Ayala
Investigators
FDA investigators tied to this site in the record.
Dianiris C Ayala2 insp.
Barbara T Carmichael2 insp.
Ivan E Reyes1 insp.
Nerming V Briones1 insp.
Kip J Hanks1 insp.
Cody D Rickman1 insp.
Colleen M Aspinwall1 insp.
Gabriel E Muniz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.140(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.40(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind OneBlood, Inc.'s 5 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