FDA Inspection 578052 — Designs For Vision, Inc.
The FDA completed an inspection of Designs For Vision, Inc. on March 19, 2009 in Bohemia, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 19, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bohemia, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2602 | 21 CFR 820.30(d) | Design output - review and approval |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3673 | 21 CFR 820.30(c) | Design input approval documentation |