FDA Inspection 1323746 — Tektone Sound & Signal Mfg.Inc.
The FDA completed an inspection of Tektone Sound & Signal Mfg.Inc. on Jun 25, 2026 in Franklin, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Franklin, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23028 | ISO 13485:2016 Clause 4.1.6 | QMS software not validated prior to use or changes |
| 23161 | ISO 13485:2016 Clause 7.5.3 | Device installation and verification records not maintained |
| 23163 | ISO 13485:2016 Clause 7.5.4 | Records of servicing activities not analyzed |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 23259 | ISO 13485:2016 Clause 8.5.2 | Corrective action records not maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |