FDA Inspection 844381 — JICE Pharmaceuticals Company
The FDA completed an inspection of JICE Pharmaceuticals Company on August 15, 2013 in Belding, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 15, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Belding, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4403 | 21 CFR 211.194(b) | Test method modification records do not include |