FDA Inspection
HRF, IncHRF, Inc – FDA Inspection, Mar 20, 2019
Record Details
This FDA Inspection record concerns HRF, Inc, with an inspection on March 20, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 77be4f80-b8c6-4d7b-a3c6-4657b5b176bb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083359
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 630.10(f)(3)Physical Assessment Determination - Hemoglobin or Hematocrit
- 21 CFR 600.12(a)Maintenance - concurrence
- 21 CFR 606.100(b)(1)Donor criteria
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Other FDA inspections of HRF, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2025 | Not classified | Atlanta District Office | |
| July 27, 2021 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 18, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 1, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 20, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for HRF, Inc
- FDA Inspection 1283202 - 2025-09-17
- FDA Inspection 1147778 - 2021-07-27
- FDA Inspection 963380 - 2016-03-18
- FDA Inspection 821175 - 2013-03-01
- FDA Inspection 630078 - 2009-11-20
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