FDA Inspection 994821 — Vita-Herb Nutriceuticals Inc
The FDA completed an inspection of Vita-Herb Nutriceuticals Inc on December 12, 2016 in Placentia, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 12, 2016
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Placentia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |