FDA Inspection 1078089 — Wisdom Pharmaceutical Co., Ltd.
The FDA completed an inspection of Wisdom Pharmaceutical Co., Ltd. on Jan 18, 2019 in Haimen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 18, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Haimen (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |