FDA Inspection
Zoe Medical IncorporatedZoe Medical Incorporated – FDA Inspection, May 31, 2024
Record Details
This FDA Inspection record concerns Zoe Medical Incorporated, with an inspection on May 31, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b56e9a80-22f9-4372-a3b1-1163c3666bae
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1240475
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of Zoe Medical Incorporated
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| April 20, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Zoe Medical Incorporated
- FDA Inspection 1102382 - 2019-09-20
- FDA Inspection 990061 - 2016-10-12
- FDA Inspection 817988 - 2013-02-07
- FDA Inspection 657853 - 2010-04-20
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