FDA Inspection 1018440 — Minato Pharmaceutical Co Ltd
The FDA completed an inspection of Minato Pharmaceutical Co Ltd on July 19, 2017 in Nasushiobara. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 19, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Nasushiobara (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15739 | 21 CFR 111.210(h)(3)(ii)(B) | Components; add, verify |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |