FDA Inspection 647152 — Ivy Animal Health Inc
The FDA completed an inspection of Ivy Animal Health Inc on February 17, 2010 in Overland Park, 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
- February 17, 2010
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Overland Park, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2016 | 21 CFR 211.188(b)(4) | Weights and Measures of Components Used |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 4309 | 21 CFR 211.84(c)(2) | Containers sampled so as to prevent contamination |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4395 | 21 CFR 211.186(b)(4) | Weight or measure of each component |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |