FDA inspection
AGC Biologics, Inc.: FDA inspection ending Feb 10, 2023
FDA inspection 1197098 · Voluntary Action Indicated (VAI) · Bothell, WA
Key facts
| Inspection ID | 1197098 |
|---|---|
| Firm | AGC Biologics, Inc. |
| FEI number | 3000209996 |
| Address | 21511 23rd Dr Se |
| City | Bothell |
| State | WA |
| ZIP | 98021 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | Feb 10, 2023 |
| 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