FDA Inspection 629670 — Bausch & Lomb Incorporated
The FDA completed an inspection of Bausch & Lomb Incorporated on November 24, 2009 in Rochester, NY. 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
- November 24, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rochester, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |