Company
United StatesAvera McKennan Hospital & University Health Center, Sioux Falls, SD – FDA Inspections
Inspection records and compliance data for Avera McKennan Hospital & University Health Center in Sioux Falls, South Dakota. 6 FDA inspections on record, last inspected October 25, 2023.
Company Profile
This profile covers Avera McKennan Hospital & University Health Center based in Sioux Falls, South Dakota, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected July 1, 2010. Last inspected October 25, 2023.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs1 inspection
- Following manufacturer"s instructions1 inspection
- Notification w/in 8 weeks1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 25, 2023 | NAI | Biologics · Blood and Blood Products | 1223896 |
| September 28, 2018 | NAI | Biologics · Blood and Blood Products | 1068082 |
| September 29, 2016 | NAI | Biologics · Blood and Blood Products | 986752 |
| October 3, 2014 | NAI | Biologics · Blood and Blood Products | 897538 |
| September 18, 2012 | NAI | Biologics · Blood and Blood Products | 799281 |
| July 1, 2010 | VAI | Biologics · Blood and Blood Products | 673560 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Avera McKennan Hospital & University Health Center
FEI Number
1772097
Address
1325 S Cliff Ave, Sioux Falls, South Dakota 57105, United States
Country
United States
ID: f63fb829-dcbb-49c3-8d0e-e0e3f1dec2ef