FDA Inspection
SureTek MedicalSureTek Medical – FDA Inspection, Jul 25, 2012
Record Details
This FDA Inspection record concerns SureTek Medical, with an inspection on July 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SureTek Medical
- Inspection Date
- July 25, 2012
- Product Type
- Devices
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ID · 9c2c7799-3c99-4921-9a65-2aaf92d4156f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 797481
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of SureTek Medical
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2026 | Not classified | Atlanta District Office | Compliance: Medical Devices |
| September 23, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 10, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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