FDA Inspection 1111871 — Kyowa Hakko Bio Co., Ltd.
The FDA completed an inspection of Kyowa Hakko Bio Co., Ltd. on November 8, 2019 in Hofu. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 8, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hofu (Japan)