FDA Inspection
SureTek MedicalSureTek Medical – FDA Inspection, Mar 6, 2026
Record Details
This FDA Inspection record concerns SureTek Medical, with an inspection on March 6, 2026, issued by the Atlanta District Office, covering medical devices & rad health.
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ID · d09b201a-b96d-4ada-8f27-20cfcdc2f784
Inspection Facts
- Inspection number
- 1305850
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.1Required elements not determined in planning product realization
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Other FDA inspections of SureTek Medical
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2016 | VAI | Center for Devices and Radiological Health | Compliance: 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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