FDA Inspection 974314 — Shionogi Pharma Co., Ltd.
The FDA completed an inspection of Shionogi Pharma Co., Ltd. on Jun 3, 2016 in Amagasaki. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 3, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Amagasaki (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |