FDA Inspection 742873 — Animal Health International, Inc dba Lextron, Inc
The FDA completed an inspection of Animal Health International, Inc dba Lextron, Inc on August 26, 2011 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). 11 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 26, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Garden City, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |