FDA Inspection
Donor Services of Indiana, Inc.Donor Services of Indiana, Inc. – FDA Inspection, Mar 29, 2010
Record Details
This FDA Inspection record concerns Donor Services of Indiana, Inc., with an inspection on March 29, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 29, 2010
- Product Type
- Biologics
View Company Profile
ID · a86ce9c8-b233-454f-a562-a5a9b90605d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 657948
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.260(d)Corrective actions
- 21 CFR 1271.50(b)(2)Donor testing not negative for CD agents
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.270(a)Records maintained concurrently
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Other FDA inspections of Donor Services of Indiana, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Donor Services of Indiana, Inc.
- FDA Inspection 864435 - 2014-01-16
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