FDA Inspection
3T Medical Systems, LLC3T Medical Systems, LLC – FDA Inspection, Feb 17, 2012
Record Details
This FDA Inspection record concerns 3T Medical Systems, LLC, with an inspection on February 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- 3T Medical Systems, LLC
- Inspection Date
- February 17, 2012
- Product Type
- Devices
View Company Profile
ID · f8516716-c7b3-4cb3-9f92-78afa84554f9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769932
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 |
| March 14, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for 3T Medical Systems, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.