Company
United StatesHighridge Medical LLC, Westminster, CO – FDA Inspections
Inspection records and compliance data for Highridge Medical LLC in Westminster, Colorado. 4 FDA inspections on record, 1 Form 483, last inspected March 01, 2018.
Company Profile
This profile covers Highridge Medical LLC based in Westminster, Colorado, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 24, 2011. Last inspected March 1, 2018.
Most cited issue areas
- Report of Death or Serious Injury2 inspections
- Controlling the labeling of HCT/Ps1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 1, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1042767 |
| January 17, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1043760 |
| October 6, 2014 | VAI | Biologics, Medical Devices & Rad Health · Human Cellular, Tissue, and Gene Therapies | 898988 |
| February 24, 2011 | NAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 714332 |
FDA documents
Form 483s (1)
EIRs (1)
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Company Information
Name
Highridge Medical LLC
FEI Number
3012447612
Address
10225 Westmoor Dr, Westminster, Colorado 80021, United States
Country
United States
ID: 2942f26e-1c21-4a07-bb53-4ad4b846a382