FDA inspection
Kyowa Hakko Bio Co., Ltd.: FDA inspection ending Nov 8, 2019
FDA inspection 1111871 · Official Action Indicated (OAI) · Hofu
Key facts
| Inspection ID | 1111871 |
|---|---|
| Firm | Kyowa Hakko Bio Co., Ltd. |
| FEI number | 3002807424 |
| Address | Kyowahatsukokogyo (Kabu) Hofukojo, 1-1; Kyowa-Cho |
| City | Hofu |
| Country | Japan |
| Fiscal year | 2020 |
| Inspection end date | Nov 8, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data