FDA Inspection
DCI Donor ServicesDCI Donor Services – FDA Inspection, Dec 19, 2019
Record Details
This FDA Inspection record concerns DCI Donor Services, with an inspection on December 19, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- DCI Donor Services
- Inspection Date
- December 19, 2019
- Product Type
- Biologics
View Company Profile
ID · 7940fb1a-ba60-4b73-9172-6309fa04be2f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1113338
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DCI Donor Services
8| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 31, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 17, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 14, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 8, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for DCI Donor Services
- FDA Inspection 1266880 - 2025-04-10
- FDA Inspection 1151792 - 2021-08-31
- FDA Inspection 1034911 - 2017-11-17
- FDA Inspection 958227 - 2015-12-14
- FDA Inspection 890360 - 2014-08-08
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