Company
United StatesEastern Colorado Health Care System, Aurora, CO – FDA Inspections
Inspection records and compliance data for Eastern Colorado Health Care System in Aurora, Colorado. 7 FDA inspections on record, last inspected February 29, 2024.
Company Profile
This profile covers Eastern Colorado Health Care System based in Aurora, Colorado, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected June 10, 2010. Last inspected February 29, 2024.
Most cited issue areas
- Required records3 inspections
- Establish, maintain and follow manufacturing SOPs2 inspections
- Controlling storage temperatures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 29, 2024 | NAI | Biologics · Blood and Blood Products | 1232796 |
| February 7, 2019 | NAI | Biologics · Blood and Blood Products | 1083599 |
| June 1, 2017 | NAI | Biologics · Blood and Blood Products | 1019116 |
| March 16, 2015 | VAI | Biologics · Blood and Blood Products | 920079 |
| January 14, 2013 | VAI | Biologics · Blood and Blood Products | 813939 |
| January 24, 2012 | VAI | Biologics · Blood and Blood Products | 765236 |
| June 10, 2010 | VAI | Biologics · Blood and Blood Products | 667872 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Eastern Colorado Health Care System
FEI Number
1770147
Address
1700 N. Wheeling St. (Az-00), Aurora, Colorado 80045, United States
Country
United States
ID: d6c9b19e-d256-42b2-bcdf-544fbcd1194a