FDA inspection
FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office: FDA inspection ending Sep 12, 2019
FDA inspection 1115202 · Official Action Indicated (OAI) · Hitachiomiya
Key facts
| Inspection ID | 1115202 |
|---|---|
| Firm | FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office |
| FEI number | 3010516924 |
| Address | 4112, Tono |
| City | Hitachiomiya |
| Country | Japan |
| Fiscal year | 2019 |
| Inspection end date | Sep 12, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
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