FDA Inspection 611733 — Nova-Tech, Inc.
The FDA completed an inspection of Nova-Tech, Inc. on September 22, 2009 in Grand Island, NE. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 22, 2009
- Fiscal Year
- 2009
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Grand Island, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1431 | 21 CFR 211.42(c)(10)(ii) | Temperature / Humidity Controls |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |