FDA Inspection 1321784 — Nikken Medical Corporation
The FDA completed an inspection of Nikken Medical Corporation on Jun 12, 2026 in Fujinomiya. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 12, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Fujinomiya (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 3062 | 21 CFR 114.10 | Personnel |
| 3067 | 21 CFR 114.80(a) | Quality control procedures |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3078 | 21 CFR 114.80(b) | Code - required elements |