Overview
- 8 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-02-18.
At a glance
Inspections
8
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Feb 2025 | Biologics | Clean | |
| 9 May 2023 | Biologics | Clean | |
| 7 Mar 2019 – 8 Mar 2019 | Biologics | Clean | |
| 20 Dec 2016 | Biologics | Clean | |
| 9 Oct 2014 | Biologics | Clean | |
| 30 Jan 2013 | Not recorded | Clean | |
| 3 Dec 2010 | Not recorded | 483 | View 483 → |
| 16 Mar 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Dec 2010
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Jana L Caylor, Nelson E Venerio
3 Dec 2010
21 CFR 606.170(a)
Adverse Reaction - Investigations
Cited by Jana L Caylor, Nelson E Venerio
Investigators
FDA investigators tied to this site in the record.
Barbara T Carmichael4 insp.
Angela E Glenn2 insp.
Steen N Graham1 insp.
Jana L Caylor1 insp.
Nelson E Venerio1 insp.
Ronnie E Jackson1 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 | 1x |
| 21 CFR 606.170(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind OneBlood, Inc.'s 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