FDA Inspection 1254558 — Pathy Medical, LLC
The FDA completed an inspection of Pathy Medical, LLC on Nov 19, 2024 in Eden Prairie, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 19, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Eden Prairie, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |