FDA Inspection 1065785 — Yangzhou Sion Commodity Co., Ltd.
The FDA completed an inspection of Yangzhou Sion Commodity Co., Ltd. on Jul 20, 2018 in Yangzhou. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 20, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yangzhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 3615 | 21 CFR 211.160(b)(4) | Test devices not meeting specifications |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |