FDA Inspection
GenTrac, Inc.GenTrac, Inc. – FDA Inspection, Sep 12, 2019
Record Details
This FDA Inspection record concerns GenTrac, Inc., with an inspection on September 12, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 731fb276-7d31-4ce3-b0fe-845ce80307c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102063
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
Other FDA inspections of GenTrac, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2025 | Not classified | Minneapolis District Office | |
| August 28, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 21, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 21, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 28, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for GenTrac, Inc.
- FDA Inspection 1276987 - 2025-07-30
- FDA Inspection 1028126 - 2017-08-28
- FDA Inspection 855328 - 2013-11-21
- FDA Inspection 776592 - 2012-03-21
- FDA Inspection 644677 - 2010-01-28
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