FDA Inspection
University of Vermont Health Network - Adirondack Blood CenterUniversity of Vermont Health Network - Adirondack Blood Center – FDA Inspection, Jul 22, 2010
Record Details
This FDA Inspection record concerns University of Vermont Health Network - Adirondack Blood Center, with an inspection on July 22, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 22, 2010
- Product Type
- Biologics
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ID · 1e4ad4d4-921d-4f9e-87b2-2b7a42f031ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 672260
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 640.3(f)Donations in less than eight weeks
- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 640.25(a)Storage temps./agitation
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of University of Vermont Health Network - Adirondack Blood Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 28, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| November 29, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 12, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 17, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for University of Vermont Health Network - Adirondack Blood Center
- FDA Inspection 1245907 - 2024-08-01
- FDA Inspection 1177423 - 2022-07-28
- FDA Inspection 1079201 - 2018-11-29
- FDA Inspection 1014179 - 2017-05-12
- FDA Inspection 922784 - 2015-04-17
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