Company
United StatesTegra Medical, LLC, Franklin, MA – FDA Inspections
Inspection records and compliance data for Tegra Medical, LLC in Franklin, Massachusetts. 2 FDA inspections on record, last inspected January 20, 2012.
Company Profile
This profile covers Tegra Medical, LLC based in Franklin, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected March 18, 2009. Last inspected January 20, 2012.
Most cited issue areas
- Lack of or inadequate DHR procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Rationale documented for no investigation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 20, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 768849 |
| March 18, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 570521 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Tegra Medical, LLC
FEI Number
3002758924
Address
9 Forge Pkwy, Franklin, Massachusetts 02038, United States
Country
United States
ID: 331230af-e141-44a2-bac3-74d96f878889