FDA Inspection
Zoe Medical IncorporatedZoe Medical Incorporated – FDA Inspection, Apr 20, 2010
Record Details
This FDA Inspection record concerns Zoe Medical Incorporated, with an inspection on April 20, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zoe Medical Incorporated
- Inspection Date
- April 20, 2010
- Product Type
- Devices
View Company Profile
ID · f6843162-9a24-4fdf-ad42-a7432e597e4b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 657853
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(d)(1)DMR required activities {see also 820.181}
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 806.20(a)Records not kept
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 |
| February 7, 2013 | VAI | Center for Devices and Radiological Health | Compliance: 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 817988 - 2013-02-07
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