Company
United StatesUniversity Of Colorado Hospital Clinical Laboratory, Aurora, CO – FDA Inspections
Inspection records and compliance data for University Of Colorado Hospital Clinical Laboratory in Aurora, Colorado. 7 FDA inspections on record, last inspected August 01, 2024.
Company Profile
This profile covers University Of Colorado Hospital Clinical Laboratory based in Aurora, Colorado, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 1
- NAI
- 6
- Form 483s
- 0
- Warning letters
- 0
First inspected August 30, 2011. Last inspected August 1, 2024.
Most cited issue areas
- Controlling storage temperatures1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
- Person performing, test results, interpretation1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 1, 2024 | NAI | Biologics · Blood and Blood Products | 1247118 |
| January 10, 2020 | NAI | Biologics · Blood and Blood Products | 1115615 |
| August 3, 2018 | NAI | Biologics · Blood and Blood Products | 1061865 |
| March 24, 2017 | NAI | Biologics · Blood and Blood Products | 1010569 |
| November 10, 2014 | NAI | Biologics · Blood and Blood Products | 906144 |
| January 30, 2013 | VAI | Biologics · Blood and Blood Products | 816364 |
| August 30, 2011 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 743406 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
University Of Colorado Hospital Clinical Laboratory
FEI Number
3003233482
Address
12425 E 16th Ave Aip 3 Room 2880, Aurora, Colorado 80045, United States
Country
United States
ID: 53be5a8e-829d-40aa-90b6-823b93103bfc