FDA Inspection
OneBlood, Inc.OneBlood, Inc. – FDA Inspection, Jun 29, 2018
Record Details
This FDA Inspection record concerns OneBlood, Inc., with an inspection on June 29, 2018, issued by the Florida District Office, covering biologics.
- Office
- Florida District Office
- People
- Colleen M. Aspinwall (Issuing Officer)
- Ivan E. Reyes (Issuing Officer)
- Lura D. Kelly (Issuing Officer)
- Samantha J. Pinizzotto (Company Rep)
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ID · 60466db9-6b30-4cba-91d3-34f95e14fc40
Inspection Facts
- Inspection number
- 1057380
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.160(e)(1)Donor deferral record - each location
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Other FDA inspections of OneBlood, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2025 | VAI | Florida District Office | Blood and Blood Products |
| November 19, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| August 19, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 29, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 21, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for OneBlood, Inc.
- FDA Inspection 1253990 - 2025-06-06
- FDA Inspection 1160059 - 2021-11-19
- FDA Inspection 987206 - 2016-08-19
- FDA Inspection 893702 - 2014-08-29
- FDA Inspection 845254 - 2013-08-21
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