Company
United StatesVitalant, Highlands Ranch, CO – FDA Inspections
Inspection records and compliance data for Vitalant in Highlands Ranch, Colorado. 7 FDA inspections on record, last inspected April 25, 2024.
Company Profile
This profile covers Vitalant based in Highlands Ranch, Colorado, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected January 20, 2010. Last inspected April 25, 2024.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs2 inspections
- Donor eligibility1 inspection
- Qualifications of donor - disease transmissible by blood1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 25, 2024 | NAI | Biologics · Blood and Blood Products | 1238350 |
| October 31, 2018 | NAI | Biologics · Blood and Blood Products | 1075128 |
| December 6, 2016 | NAI | Biologics · Blood and Blood Products | 998083 |
| February 6, 2015 | NAI | Biologics · Blood and Blood Products | 913381 |
| October 30, 2013 | NAI | Biologics · Blood and Blood Products | 856431 |
| November 1, 2011 | VAI | Biologics · Blood and Blood Products | 752456 |
| January 20, 2010 | VAI | Biologics · Blood and Blood Products | 642967 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
UCHealth Highlands Ranch Hospital
Department of Defense - Army
ClinImmune Labs-Univ Colorado Cord Blood Bank
CNY Fertility Colorado PLLC
Marathon Medical Corporation
Trilogy Mountain States Colorado
Parker Adventist Hospital
Tridens Biologics, LLC.
Fertility Laboratories of Colorado, LLC
Parkview Episcopal Hospital BB
Company Information
Name
Vitalant
FEI Number
3002921197
Address
Parkway Center, 541 W Highlands Ranch Pkwy Bldg 2, Highlands Ranch, Colorado 80129, United States
Country
United States
ID: 9255f2bb-a84f-4709-80e5-4bdc48212a2f