Company
United StatesTektone Sound & Signal Mfg.Inc., Franklin, NC – FDA Inspections
Inspection records and compliance data for Tektone Sound & Signal Mfg.Inc. in Franklin, North Carolina. 4 FDA inspections on record, 2 Form 483s, last inspected June 25, 2026.
Company Profile
This profile covers Tektone Sound & Signal Mfg.Inc. based in Franklin, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected June 16, 2011. Last inspected June 25, 2026.
Most cited issue areas
- Lack of Written MDR Procedures2 inspections
- Complaint handling records not maintained1 inspection
- Corrective action records not maintained1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 25, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1323746 |
| September 26, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1102966 |
| July 9, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 887864 |
| June 16, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 731943 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Tektone Sound & Signal Mfg.Inc.
FEI Number
3001757821
Address
324 Industrial Park Rd, Franklin, North Carolina 28734, United States
Country
United States
ID: 78e7d2c1-ec39-4826-8b0e-abf57a1b51c8