FDA Inspection 822788 — DEC International NZ, Ltd.
The FDA completed an inspection of DEC International NZ, Ltd. on Feb 28, 2013 in Hamilton. 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). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 28, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Hamilton (New Zealand)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4324 | 21 CFR 211.110(b) | In-process materials specifications testing |