FDA Inspection 682591 — CIBA Vision Puerto Rico, Inc.
The FDA completed an inspection of CIBA Vision Puerto Rico, Inc. on September 2, 2010 in Cidra, PR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 2, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cidra, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |