Company
United StatesTranS1, Wilmington, NC – FDA Inspections
Inspection records and compliance data for TranS1 in Wilmington, North Carolina. 3 FDA inspections on record, 1 Form 483, last inspected June 12, 2017.
Company Profile
This profile covers TranS1 based in Wilmington, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected May 26, 2010. Last inspected June 12, 2017.
Most cited issue areas
- Lack of or inadequate procedures for distribution1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 12, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1013952 |
| September 11, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 848298 |
| May 26, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 664956 |
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
TranS1
FEI Number
3011302058
Address
2712 Exchange Dr Ste C, Wilmington, North Carolina 28403, United States
Country
United States
ID: efda4279-140d-403d-a314-59e941524905