FDA Inspection 684625 — JICE Pharmaceuticals Company
The FDA completed an inspection of JICE Pharmaceuticals Company on October 4, 2010 in Belding, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 4, 2010
- Fiscal Year
- 2011
- 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 |
| 1541 | 21 CFR 211.125(b) | Examination of issued labels |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4375 | 21 CFR 211.188(b)(5) | In-process and laboratory control results |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |