FDA Inspection 1267026 — Sunsho Pharmaceutical Co., Ltd.
The FDA completed an inspection of Sunsho Pharmaceutical Co., Ltd. on Apr 17, 2025 in Fuji. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 17, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Fuji (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15785 | 21 CFR 111.410(b) | Label, packaging - discrepancies |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22885 | 21 CFR 111.205(a) | Master manufacturing record - followed |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |