FDA Inspection 1311004 — Robling Medical LLC
The FDA completed an inspection of Robling Medical LLC on Apr 6, 2026 in Youngsville, NC. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 6, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Youngsville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23256 | ISO 13485:2016 Clause 8.5.2 | Corrective actions were unduly delayed |