FDA Inspection 704851 — Bausch & Lomb Incorporated
The FDA completed an inspection of Bausch & Lomb Incorporated on December 17, 2010 in Greenville, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 17, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Greenville, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |