Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
TSTektone Sound & Signal Mfg.Inc.Franklin, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 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 483 report
Get the verbatim text of all 6 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere