Company
United StatesPresbyterian/St. Luke's Medical Center Donor Services, Denver, CO – FDA Inspections
Inspection records and compliance data for Presbyterian/St. Luke's Medical Center Donor Services in Denver, Colorado. 8 FDA inspections on record, 2 Form 483s, last inspected March 07, 2024.
Company Profile
This profile covers Presbyterian/St. Luke's Medical Center Donor Services based in Denver, Colorado, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 5
- NAI
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected November 24, 2009. Last inspected March 7, 2024.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs4 inspections
- Person performing, test results, interpretation3 inspections
- Donor deferral record - each location2 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 7, 2024 | NAI | Biologics · Blood and Blood Products | 1233673 |
| April 22, 2019 | VAI | Biologics · Blood and Blood Products | 1087028 |
| January 26, 2017 | VAI | Biologics · Blood and Blood Products | 998973 |
| March 5, 2014 | VAI | Biologics · Blood and Blood Products | 868654 |
| November 30, 2012 | NAI | Biologics · Blood and Blood Products | 808541 |
| June 28, 2012 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 786441 |
| August 23, 2011 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 741768 |
| November 24, 2009 | VAI | Biologics · Blood and Blood Products | 637133 |
FDA documents
Form 483s (1)
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Company Information
Name
Presbyterian/St. Luke's Medical Center Donor Services
FEI Number
1770151
Address
1719 E 19th Ave, Professional Plaza West, Ste 6350, Denver, Colorado 80218, United States
Country
United States
ID: 5fb3f1cd-327f-47e0-bc14-cd94277fe76a