FDA Inspection
3T Medical Systems, LLC3T Medical Systems, LLC – FDA Inspection, Aug 31, 2016
Record Details
This FDA Inspection record concerns 3T Medical Systems, LLC, with an inspection on August 31, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- 3T Medical Systems, LLC
- Inspection Date
- August 31, 2016
- Product Type
- Devices
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ID · 92d3634c-688c-49a4-bcd5-b838b9d635be
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994697
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(h)Incorrect translation to production specifications
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Other FDA inspections of 3T Medical Systems, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 17, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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