FDA Inspection 753000 — Kyowa Hakko Bio Co., Ltd.
The FDA completed an inspection of Kyowa Hakko Bio Co., Ltd. on October 27, 2011 in Hofu. 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
- October 27, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hofu (Japan)