1308134
Unik Orthopedics, Inc — FEI 3019006180
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
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 23061 | ISO 13485:2016 Clause 5.6.1 | QMS not reviewed by top management at documented planned intervals |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23138 | ISO 13485:2016 Clause 7.4.1 | Procedures for purchasing process not documented |
| 23178 | ISO 13485:2016 Clause 7.5.8 | Procedures for product identification not documented |
| 23216 | ISO 13485:2016 Clause 8.2.2 | Lack of documented justification for not investigating complaint(s) |
| 23220 | ISO 13485:2016 Clause 8.2.4 | Internal audits not conducted to ensure QMS meets requirements and is effective |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |