FDA Inspection
Zoe Medical IncorporatedZoe Medical Incorporated – FDA Inspection, Sep 20, 2019
Record Details
This FDA Inspection record concerns Zoe Medical Incorporated, with an inspection on September 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bcd6ca15-f75e-48d9-a9d8-5486cfa4e52e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102382
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.50(a)(1)Documented evaluation
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 |
| October 12, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 7, 2013 | VAI | 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 990061 - 2016-10-12
- FDA Inspection 817988 - 2013-02-07
- FDA Inspection 657853 - 2010-04-20
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