FDA Inspection 951391 — Nippon Fine Chemical Co., Ltd.
The FDA completed an inspection of Nippon Fine Chemical Co., Ltd. on December 17, 2015 in Takasago. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 17, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Takasago (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 3577 | 21 CFR 211.101(b)(4) | Subdivided component/container/finished drug |