Company
United StatesHuron Regional Medical Center Blood Bank, Huron, SD – FDA Inspections
Inspection records and compliance data for Huron Regional Medical Center Blood Bank in Huron, South Dakota. 7 FDA inspections on record, last inspected July 31, 2019.
Company Profile
This profile covers Huron Regional Medical Center Blood Bank based in Huron, South Dakota, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected May 7, 2009. Last inspected July 31, 2019.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs1 inspection
- Provide space for blood withdrawal1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 31, 2019 | NAI | Biologics · Blood and Blood Products | 1098665 |
| June 14, 2017 | NAI | Biologics · Blood and Blood Products | 1018715 |
| November 5, 2014 | NAI | Biologics · Blood and Blood Products | 904775 |
| May 10, 2013 | VAI | Biologics · Blood and Blood Products | 832724 |
| July 20, 2011 | NAI | Biologics · Blood and Blood Products | 738314 |
| April 27, 2011 | VAI | Biologics · Blood and Blood Products | 726085 |
| May 7, 2009 | NAI | Biologics · Blood and Blood Products | 592210 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Spirit of the North Tissue Services
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Company Information
Name
Huron Regional Medical Center Blood Bank
FEI Number
1771181
Address
172 4th St Se, Huron, South Dakota 57350, United States
Country
United States
ID: 9a83dc2b-87a3-4551-8ed2-35ef28d26edc