FDA Inspection
DCI Donor Services dba Tennessee Donor ServicesDCI Donor Services dba Tennessee Donor Services – FDA Inspection, Dec 19, 2013
Record Details
This FDA Inspection record concerns DCI Donor Services dba Tennessee Donor Services, with an inspection on December 19, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 19, 2013
- Product Type
- Biologics
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ID · 5a13e383-c6bc-4bf4-a9a1-ef8af8569e0c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 860633
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.230(a)Validation & approval--established procedures
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Other FDA inspections of DCI Donor Services dba Tennessee Donor Services
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 12, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 27, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for DCI Donor Services dba Tennessee Donor Services
- FDA Inspection 1204335 - 2023-04-27
- FDA Inspection 965117 - 2016-01-12
- FDA Inspection 767756 - 2012-01-27
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