FDA Inspection 1111464 — Hisun Pharmaceutical (Nantong) Co., Ltd.
The FDA completed an inspection of Hisun Pharmaceutical (Nantong) Co., Ltd. on November 15, 2019 in Nantong. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 15, 2019
- Fiscal Year
- 2020
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Nantong (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |