FDA Inspection
MyCardioMyCardio – FDA Inspection, Jun 26, 2017
Record Details
This FDA Inspection record concerns MyCardio, with an inspection on June 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 4c756b32-21b9-482a-b3d5-059ffc24b38b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015573
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(i)Software validation for automated processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MyCardio
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2018 | Not classified | Denver District Office | |
| October 22, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MyCardio
- FDA Inspection 1106057 - 2018-07-18
- FDA Inspection 805529 - 2012-10-22
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.