1304224
Dick Medical Supply LLC — FEI 3005831263
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 9, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Columbus, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 23049 | ISO 13485:2016 Clause 5.1 | Lack of evidence for top management's commitment to QMS |
| 23085 | ISO 13485:2016 Clause 7.1 | Processes needed for product realization not planned and developed |
| 23139 | ISO 13485:2016 Clause 7.4.1 | Criteria for the evaluation and selection of suppliers not established |
| 23148 | ISO 13485:2016 Clause 7.4.2 | Purchasing information lacks written agreement regarding notification of changes |
| 23150 | ISO 13485:2016 Clause 7.4.3 | Purchased product verification activities not established or implemented |
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |