FDA Inspection 650235 — Epiphany Cardiography Products
The FDA completed an inspection of Epiphany Cardiography Products on Mar 5, 2010 in Midlothian, VA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Midlothian, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |