FDA Inspection
3T Medical Systems, LLC3T Medical Systems, LLC – FDA Inspection, Mar 14, 2014
Record Details
This FDA Inspection record concerns 3T Medical Systems, LLC, with an inspection on March 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- 3T Medical Systems, LLC
- Inspection Date
- March 14, 2014
- Product Type
- Devices
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ID · c48c1034-6faa-4202-8138-6412a8210123
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 869836
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of 3T Medical Systems, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 17, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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