FDA Inspection 675346 — Kyowa Hakko Bio Co. Ltd.
The FDA completed an inspection of Kyowa Hakko Bio Co. Ltd. on July 2, 2010 in Ube. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 2, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ube (Japan)