FDA Inspection 544753 — Visionary Optics, LLC
The FDA completed an inspection of Visionary Optics, LLC on Oct 27, 2008 in Front Royal, VA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 27, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Front Royal, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3416 | 21 CFR 820.70(a)(1) | Process control instructions |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 4189 | 21 CFR 820.198(a) | General |
| 538 | 21 CFR 820.70(a) | Process control procedures |