FDA Inspection 1267027 — Sunsho Pharmaceutical Co., Ltd.
The FDA completed an inspection of Sunsho Pharmaceutical Co., Ltd. on April 17, 2025 in Fuji. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 17, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Fuji (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |