FDA Inspection 1308010 — Raumedic Inc
The FDA completed an inspection of Raumedic Inc on March 13, 2026 in Mills River, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mills River, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23154 | ISO 13485:2016 Clause 7.4.3 | Records of purchased product verification not maintained |
| 23155 | ISO 13485:2016 Clause 7.5.1 | Production and service provision not adequate |
| 23170 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes lack required elements |