FDA Inspection 1031649 — Kyowa Hakko Bio Co., Ltd.
The FDA completed an inspection of Kyowa Hakko Bio Co., Ltd. on September 8, 2017 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
- September 8, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hofu (Japan)