Overview
- 10 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-07-08.
At a glance
Inspections
10
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jul 2024 | Biologics | Clean | |
| 18 Aug 2021 | Biologics | Clean | |
| 15 Mar 2019 | Biologics | Clean | |
| 27 Sep 2016 | Biologics | Clean | |
| 20 May 2014 | Biologics | Clean | |
| 27 Sep 2013 – 30 Sep 2013 | Biologics | 483 | View 483 → |
| 2 Dec 2011 | Not recorded | Clean | |
| 16 Dec 2009 | Not recorded | Clean | |
| 22 Apr 2003 | Not recorded | Clean | |
| 22 Jan 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Sep 2013
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Omayra N Rodriguez-Ruiz
Investigators
FDA investigators tied to this site in the record.
Nerming V Briones1 insp.
Sergio E Delgado1 insp.
Laura E Garcia1 insp.
Ivan E Reyes1 insp.
Gail L Katz1 insp.
Omayra N Rodriguez-Ruiz1 insp.
Heather M Bullock1 insp.
Edwin J Gorney1 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 |
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