FDA Inspection 1305052 — Jardon Eye Prosthetics, Inc.
The FDA completed an inspection of Jardon Eye Prosthetics, Inc. on March 2, 2026 in Southfield, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 2, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Southfield, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23038 | ISO 13485:2016 Clause 4.2.4 | Lack of document control |
| 23055 | ISO 13485:2016 Clause 5.5.1 | Management responsibilities and authorities not documented |
| 23060 | ISO 13485:2016 Clause 5.6.1 | Management review procedures not documented |
| 23077 | ISO 13485:2016 Clause 6.3 | Requirements for infrastructure maintenance activities not documented |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23139 | ISO 13485:2016 Clause 7.4.1 | Criteria for the evaluation and selection of suppliers not established |
| 23221 | ISO 13485:2016 Clause 8.2.4 | Internal audit procedures not documented |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |