580924
Jardon Eye Prosthetics, Inc. — FEI 1824736
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Southfield, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3159 | 21 CFR 820.184 | DHR content |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3419 | 21 CFR 820.70(a)(4) | Approval of process |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 3839 | 21 CFR 820.70(a)(4) | Approval of process equipment |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |