Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-06.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Feb 2026 – 6 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Feb 2023 – 15 Feb 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Apr 2018 – 12 Apr 2018 | Medical Devices & Rad Health | Clean | |
| 25 Sep 2014 – 1 Oct 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Jan 2012 | Not recorded | 483 | View 483 → |
| 19 Mar 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Mar 2026
ISO 13485:2016 Clause 6.4.1
Work environment requirements and procedures not documented
Cited by Jeffrey J Thibodeau
6 Mar 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Jeffrey J Thibodeau
6 Mar 2026
ISO 13485:2016 Clause 7.6
Software used for monitoring and measurement not validated
Cited by Jeffrey J Thibodeau
6 Mar 2026
ISO 13485:2016 Clause 8.3.1
Nonconforming product not identified and controlled
Cited by Jeffrey J Thibodeau
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 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.1 | 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 Linemaster Switch Corporation's 5 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