FDA Inspection 834873 — United Contact Lens, Inc.
The FDA completed an inspection of United Contact Lens, Inc. on June 7, 2013 in Arlington, 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
- June 7, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Arlington, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |