Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-25.
At a glance
Inspections
4
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jun 2026 – 25 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Sep 2019 – 26 Sep 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Jul 2014 – 9 Jul 2014 | Medical Devices & Rad Health | Clean | |
| 16 Jun 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jun 2026
ISO 13485:2016 Clause 4.1.6
QMS software not validated prior to use or changes
Cited by Benjamin E Bowen
25 Jun 2026
ISO 13485:2016 Clause 7.5.3
Device installation and verification records not maintained
Cited by Benjamin E Bowen
25 Jun 2026
ISO 13485:2016 Clause 7.5.4
Records of servicing activities not analyzed
Cited by Benjamin E Bowen
25 Jun 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling records not maintained
Cited by Benjamin E Bowen
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.120(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.1.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Tektone Sound & Signal Mfg.Inc.'s 2 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat