FDA Inspection 629659 — Bausch & Lomb Surgical, Inc.
The FDA completed an inspection of Bausch & Lomb Surgical, Inc. on November 23, 2009 in Clearwater, FL. 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 23, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Clearwater, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3149 | 21 CFR 820.180 | Availability |
| 3396 | 21 CFR 820.80(d)(1) | DMR required activities {see also 820.181} |
| 4189 | 21 CFR 820.198(a) | General |