FDA inspection
Fenwal International Inc.: FDA inspection ending Mar 4, 2024
FDA inspection 1231736 · Voluntary Action Indicated (VAI) · San German, PR
Key facts
| Inspection ID | 1231736 |
|---|---|
| Firm | Fenwal International Inc. |
| FEI number | 1000222291 |
| Address | Road 122, Km 0.5 Ave 1 |
| City | San German |
| State | PR |
| ZIP | 00683 |
| Fiscal year | 2024 |
| Inspection end date | Mar 4, 2024 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Blood and Blood Products |
| Product type | Biologics |
At a glance
- 1–9 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