FDA Inspection 610047 — Northwest Eye Design, LLC
The FDA completed an inspection of Northwest Eye Design, LLC on August 26, 2009 in Kirkland, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 26, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kirkland, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3227 | 21 CFR 820.70(g)(1) | Activity documentation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 538 | 21 CFR 820.70(a) | Process control procedures |