FDA inspection
FujiFilm Diosynth Biotechnologies U.S.A., Inc.: FDA inspection ending Apr 21, 2021
FDA inspection 1140593 · Voluntary Action Indicated (VAI) · Research Triangle Park, NC
Key facts
| Inspection ID | 1140593 |
|---|---|
| Firm | FujiFilm Diosynth Biotechnologies U.S.A., Inc. |
| FEI number | 3000718852 |
| Address | 6051 George Watts Hill Dr |
| City | Research Triangle Park |
| State | NC |
| ZIP | 27709 |
| Country | United States |
| Fiscal year | 2021 |
| Inspection end date | Apr 21, 2021 |
| Classification | Voluntary Action Indicated (VAI) |
| 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
- Yes Establishment inspection report (EIR) exists
- 10–99 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