Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-12.
At a glance
Inspections
8
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Feb 2026 – 12 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jan 2023 – 13 Jan 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Dec 2017 – 15 Dec 2017 | Medical Devices & Rad Health | Clean | |
| 9 Jul 2015 – 10 Jul 2015 | Medical Devices & Rad Health | Clean | |
| 7 Nov 2011 | Not recorded | Clean | |
| 11 Dec 2008 | Not recorded | Clean | |
| 7 Nov 2002 | Not recorded | Clean | |
| 16 Oct 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Feb 2026
ISO 13485:2016 Clause 8.2.6
Monitoring and measurement requirements of product characteristics are not met
Cited by Christina L Bigham
12 Feb 2026
ISO 13485:2016 Clause 8.2.6
Monitoring and measurement requirements of product characteristics are not met
Cited by Christina L Bigham
12 Feb 2026
ISO 13485:2016 Clause 8.3.1
Procedure for nonconforming product not documented
Cited by Christina L Bigham
12 Feb 2026
ISO 13485:2016 Clause 8.3.1
Procedure for nonconforming product not documented
Cited by Christina L Bigham
Investigators
FDA investigators tied to this site in the record.
Christina L Bigham1 insp.
Albert L Nguyen1 insp.
Kyle J Mccracken1 insp.
Benjamin W Anderson1 insp.
Jessica L Johnson1 insp.
Robert J Waldorf1 insp.
Tony T Yang1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.2.6 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.3.1 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Electromed, Inc.'s 2 Form 483s
Source PDFs 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