FDA Inspection 1287936 — Electro Medical Systems, LLC
The FDA completed an inspection of Electro Medical Systems, LLC on October 21, 2025 in Southlake, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 21, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Southlake, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3837 | 21 CFR 820.25(b) | Training records |