Company
United StatesStetrix, Inc., Bartlett, TN – FDA Inspections
Inspection records and compliance data for Stetrix, Inc. in Bartlett, Tennessee. 2 FDA inspections on record, 1 Form 483, last inspected November 17, 2023.
Company Profile
This profile covers Stetrix, Inc. based in Bartlett, Tennessee, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 6, 2019. Last inspected November 17, 2023.
Most cited issue areas
- Design input - Lack of or inadequate procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 17, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1225463 |
| February 6, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1078403 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Stetrix, Inc.
FEI Number
3005550381
Address
7531 Bartlett Corporate Cv E Ste 103, Bartlett, Tennessee 38133, United States
Country
United States
ID: 244d57a2-ba6d-4ec1-b698-e58a05280b18