Company
United StatesMyCardio, Denver, CO – FDA Inspections
Inspection records and compliance data for MyCardio in Denver, Colorado. 3 FDA inspections on record, 2 Form 483s, last inspected July 18, 2018.
Company Profile
This profile covers MyCardio based in Denver, Colorado, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected October 22, 2012. Last inspected July 18, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Software validation for automated processes1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 18, 2018 | Not classified | Medical Devices & Rad Health | 1106057 |
| June 26, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1015573 |
| October 22, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 805529 |
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
MyCardio
FEI Number
3009498109
Address
3003 E 3rd Ave Ste 201, Denver, Colorado 80206, United States
Country
United States
ID: 4dd43f03-4c2e-4c5c-8881-e309ce01b976