FDA Inspection
Sanford Medical CenterSanford Medical Center – FDA Inspection, Mar 26, 2010
Record Details
This FDA Inspection record concerns Sanford Medical Center, with an inspection on March 26, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Sanford Medical Center
- Inspection Date
- March 26, 2010
- Product Type
- Biologics
View Company Profile
ID · 03ae13d9-1079-4432-9186-0d405769a74b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 654608
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 640.24(b)Storage until removal of platelets
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 640.4(f)Arm preparation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Sanford Medical Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 27, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 6, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 31, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 20, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Sanford Medical Center
- FDA Inspection 1325596 - 2026-06-18
- FDA Inspection 1223377 - 2023-10-27
- FDA Inspection 1067120 - 2018-09-06
- FDA Inspection 926726 - 2015-03-31
- FDA Inspection 838004 - 2013-06-20
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