FDA Inspection 635209 — Labtician Ophthalmics Inc.
The FDA completed an inspection of Labtician Ophthalmics Inc. on Nov 5, 2009 in Oakville. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 5, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oakville (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |