FDA Inspection 580924 — Jardon Eye Prosthetics, Inc.
The FDA completed an inspection of Jardon Eye Prosthetics, Inc. on April 30, 2009 in Southfield, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: 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 |