FDA Inspection
Avera Sacred Heart Hospital/Blood BankAvera Sacred Heart Hospital/Blood Bank – FDA Inspection, Jan 28, 2011
Record Details
This FDA Inspection record concerns Avera Sacred Heart Hospital/Blood Bank, with an inspection on January 28, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 28, 2011
- Product Type
- Biologics
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ID · 7c7bc289-7a65-4c61-ac3d-591126562a95
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 708638
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Avera Sacred Heart Hospital/Blood Bank
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 16, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 28, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Avera Sacred Heart Hospital/Blood Bank
- FDA Inspection 1103371 - 2019-09-30
- FDA Inspection 993339 - 2016-11-16
- FDA Inspection 809597 - 2012-11-28
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