FDA Inspection 929606 — Epiphany Cardiography Products
The FDA completed an inspection of Epiphany Cardiography Products on Jun 11, 2015 in Midlothian, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 11, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Midlothian, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |