FDA Inspection
Zoe Medical IncorporatedZoe Medical Incorporated – FDA Inspection, Feb 7, 2013
Record Details
This FDA Inspection record concerns Zoe Medical Incorporated, with an inspection on February 7, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zoe Medical Incorporated
- Inspection Date
- February 7, 2013
- Product Type
- Devices
View Company Profile
ID · e91e28a8-f282-42a1-855c-8dbc04fcaf3f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 817988
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zoe Medical Incorporated
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 20, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 12, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 20, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Zoe Medical Incorporated
- FDA Inspection 1240475 - 2024-05-31
- FDA Inspection 1102382 - 2019-09-20
- FDA Inspection 990061 - 2016-10-12
- FDA Inspection 657853 - 2010-04-20
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