FDA Inspection 1085068 — Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd.
The FDA completed an inspection of Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd. on March 15, 2019 in Kunshan. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 15, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kunshan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |