FDA Inspection
Tektone Sound & Signal Mfg.Inc.Tektone Sound & Signal Mfg.Inc. – FDA Inspection, Jun 25, 2026
Record Details
This FDA Inspection record concerns Tektone Sound & Signal Mfg.Inc., with an inspection on June 25, 2026, issued by the Atlanta District Office, covering medical devices & rad health.
- Inspection Date
- June 25, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 5c0d7e3d-880f-433c-9bbb-3804a34d6003
Inspection Facts
- Inspection number
- 1323746
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 4.1.6QMS software not validated prior to use or changes
- ISO 13485:2016 Clause 7.5.3Device installation and verification records not maintained
- ISO 13485:2016 Clause 7.5.4Records of servicing activities not analyzed
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
- ISO 13485:2016 Clause 8.5.2Corrective action records not maintained
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Other FDA inspections of Tektone Sound & Signal Mfg.Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 9, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 16, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Tektone Sound & Signal Mfg.Inc.
- FDA Inspection 1102966 - 2019-09-26
- FDA Inspection 887864 - 2014-07-09
- FDA Inspection 731943 - 2011-06-16
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