FDA Inspection 799524 — Bausch & Lomb Incorporated
The FDA completed an inspection of Bausch & Lomb Incorporated on Sep 6, 2012 in Rochester, NY. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 6, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Rochester, NY (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14523 | 21 CFR 812.43(c) | No investigator agreement |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2937 | 21 CFR 812.43(c)(1) | No curriculum vitae in investigator agreement |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |