Company
United States3T Medical Systems, LLC, Canton, MI – FDA Inspections
Inspection records and compliance data for 3T Medical Systems, LLC in Canton, Michigan. 3 FDA inspections on record, last inspected August 31, 2016.
Company Profile
This profile covers 3T Medical Systems, LLC based in Canton, Michigan, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected February 17, 2012. Last inspected August 31, 2016.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of Written MDR Procedures2 inspections
- Design review - documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 31, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 994697 |
| March 14, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 869836 |
| February 17, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 769932 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
3T Medical Systems, LLC
FEI Number
3003261020
Address
41157 Capital Dr, Canton, Michigan 48187, United States
Country
United States
ID: c82f2fbc-8da2-46a0-ae34-4a5d880e0e7c