FDA Inspection 1114781 — Northwest Eye Design, LLC
The FDA completed an inspection of Northwest Eye Design, LLC on January 10, 2020 in Kirkland, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 10, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kirkland, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |