754510
Dharma Research, Inc. — FEI 3010131268
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 23, 2011
- Fiscal Year
- 2012
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |