FDA Inspection 1307498 — R2 Digital Milling Technologies Inc.
The FDA completed an inspection of R2 Digital Milling Technologies Inc. on March 12, 2026 in Westwood, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 12, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Westwood, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 23039 | ISO 13485:2016 Clause 4.2.4 | Document Control Procedure Inadequate |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23127 | ISO 13485:2016 Clause 7.3.8 | Design and development transfer procedures not documented |
| 23145 | ISO 13485:2016 Clause 7.4.1 | Records of supplier (re)evaluation, selection, and monitoring not maintained |
| 23155 | ISO 13485:2016 Clause 7.5.1 | Production and service provision not adequate |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 23220 | ISO 13485:2016 Clause 8.2.4 | Internal audits not conducted to ensure QMS meets requirements and is effective |
| 23236 | ISO 13485:2016 Clause 8.3.1 | Nonconforming product not identified and controlled |