Atlas

FDA-Inspected Site

OneBlood, Inc.

13 FDA inspections are on record for OneBlood, Inc. in St Petersburg, United States.

483· Form 483 issued

St Petersburg, United States · Last updated July 10, 2026

Overview

  • 13 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-06-06.

At a glance

Inspections

13

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Jun 2025 – 6 Jun 2025Biologics483View 483 →
15 Nov 2021 – 19 Nov 2021BiologicsClean
25 Jun 2018 – 29 Jun 2018Biologics483View 483 →
15 Aug 2016 – 19 Aug 2016BiologicsClean
22 Aug 2014 – 29 Aug 2014BiologicsClean
13 Aug 2013 – 21 Aug 2013BiologicsClean
5 May 2011Not recordedClean
27 Aug 2009Not recordedClean
31 May 2007Not recordedClean
14 Jun 2005Not recordedClean
6 Aug 2002Not recordedClean
1 Sep 2000Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

6 Jun 2025
21 CFR 606.171

Biological product deviation report

Cited by Annette Melendez, Laura E Garcia, Steen N Graham

29 Jun 2018
21 CFR 606.160(e)(1)

Donor deferral record - each location

Cited by Ivan E Reyes, Lura D Baquero, Samantha J Pinizzotto, Colleen M Aspinwall

Investigators

FDA investigators tied to this site in the record.

Samantha J Pinizzotto5 insp.
Mizanne E Lewis3 insp.
Ivan E Reyes2 insp.
Jana L Caylor2 insp.
Annette Melendez1 insp.
Laura E Garcia1 insp.
Steen N Graham1 insp.
Barbara T Carmichael1 insp.
Amanda B Vega1 insp.
Lura D Baquero1 insp.
Colleen M Aspinwall1 insp.
Lundy H Patrick1 insp.
Joan S Norton1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 606.160(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 606.171Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind OneBlood, Inc.'s 2 Form 483s

Source PDFs 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