FDA Inspection
SureTek MedicalSureTek Medical – FDA Inspection, Sep 23, 2016
Record Details
This FDA Inspection record concerns SureTek Medical, with an inspection on September 23, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SureTek Medical
- Inspection Date
- September 23, 2016
- Product Type
- Devices
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ID · 26ba7508-ad72-42f7-a098-d9c40c68b655
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988803
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SureTek Medical
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2026 | Not classified | Atlanta District Office | Compliance: Medical Devices |
| November 10, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 25, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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