FDA Inspection 609844 — Ben Venue Laboratories Inc
The FDA completed an inspection of Ben Venue Laboratories Inc on September 17, 2009 in Bedford, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 17, 2009
- Fiscal Year
- 2009
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Bedford, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 1979 | 21 CFR 211.182 | Chronological Order of Equipment Log Entries |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |