FDA Inspection 1267706 — R-Med Inc
The FDA completed an inspection of R-Med Inc on Apr 23, 2025 in Oregon, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 23, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oregon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |