FDA Inspection 982746 — JICE Pharmaceuticals Company
The FDA completed an inspection of JICE Pharmaceuticals Company on July 26, 2016 in Belding, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 26, 2016
- Fiscal Year
- 2016
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Belding, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |