FDA Inspection
DonorConnectDonorConnect – FDA Inspection, Aug 20, 2019
Record Details
This FDA Inspection record concerns DonorConnect, with an inspection on August 20, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · bed1146b-01cd-4f66-b1c0-7a6b5dd7c8f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100689
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.215Potential problems with recovery
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DonorConnect
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2025 | Not classified | Denver District Office | |
| June 22, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 14, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 8, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 26, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for DonorConnect
- FDA Inspection 1282450 - 2025-09-05
- FDA Inspection 980883 - 2016-06-22
- FDA Inspection 823576 - 2013-03-14
- FDA Inspection 773542 - 2012-03-08
- FDA Inspection 622838 - 2009-10-26
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