FDA Inspection 1303288 — Electromed, Inc.
The FDA completed an inspection of Electromed, Inc. on February 12, 2026 in New Prague, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 12, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- New Prague, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23230 | ISO 13485:2016 Clause 8.2.6 | Monitoring and measurement requirements of product characteristics are not met |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |