FDA Inspection
Epiphany Cardiography ProductsEpiphany Cardiography Products – FDA Inspection, Jun 11, 2015
Record Details
This FDA Inspection record concerns Epiphany Cardiography Products, with an inspection on June 11, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 11, 2015
- Product Type
- Devices
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ID · 8084c6ed-0f6b-490b-ab49-4d9356b9e198
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 929606
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of Epiphany Cardiography Products
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 5, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Epiphany Cardiography Products
- FDA Inspection 1057632 - 2018-04-17
- FDA Inspection 650235 - 2010-03-05
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