FDA Inspection 680930 — Animal Health International, Inc dba Lextron, Inc
The FDA completed an inspection of Animal Health International, Inc dba Lextron, Inc on August 30, 2010 in Garden City, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 30, 2010
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Garden City, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 15019 | 21 CFR 1271.160(d) | Computer software verification |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4403 | 21 CFR 211.194(b) | Test method modification records do not include |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |