FDA Inspection
Avera McKennan Hospital & University Health CenterAvera McKennan Hospital & University Health Center – FDA Inspection, Jul 1, 2010
Record Details
This FDA Inspection record concerns Avera McKennan Hospital & University Health Center, with an inspection on July 1, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 1, 2010
- Product Type
- Biologics
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ID · 89122432-6688-4834-a05a-15332d227ff3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 673560
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 630.40(c)Notification w/in 8 weeks
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Avera McKennan Hospital & University Health Center
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 28, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 29, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 3, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 18, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Avera McKennan Hospital & University Health Center
- FDA Inspection 1223896 - 2023-10-25
- FDA Inspection 1068082 - 2018-09-28
- FDA Inspection 986752 - 2016-09-29
- FDA Inspection 897538 - 2014-10-03
- FDA Inspection 799281 - 2012-09-18
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