FDA Inspection 637948 — CIBA Vision Puerto Rico, Inc.
The FDA completed an inspection of CIBA Vision Puerto Rico, Inc. on December 9, 2009 in Cidra, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 9, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cidra, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3302 | 21 CFR 820.100(a)(3) | Identifying corrective & preventive actions |
| 4189 | 21 CFR 820.198(a) | General |