FDA Inspection 742873 — Animal Health International, Inc
The FDA completed an inspection of Animal Health International, Inc on Aug 26, 2011 in Garden City, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 11 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 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 |