FDA Inspection
DonorConnectDonorConnect – FDA Inspection, Mar 8, 2012
Record Details
This FDA Inspection record concerns DonorConnect, with an inspection on March 8, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- DonorConnect
- Inspection Date
- March 8, 2012
- Product Type
- Biologics
View Company Profile
ID · 6a36feea-98e0-4422-b75a-b3a539f210bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 773542
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.180(d)Adopted from another organization
- 21 CFR 1271.80(d)(2)Plasma diluted test specimens
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.350(b)(1)Deviations not investigated
- 21 CFR 1271.215Potential problems with recovery
- 21 CFR 1271.180(a)Procedures to meet core CTGP
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 | |
| August 20, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 |
| 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 1100689 - 2019-08-20
- FDA Inspection 980883 - 2016-06-22
- FDA Inspection 823576 - 2013-03-14
- FDA Inspection 622838 - 2009-10-26
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