FDA inspection
Fenwal International, Inc.: FDA inspection ending Apr 25, 2023
FDA inspection 1203534 · Voluntary Action Indicated (VAI) · Bajos De Haina
Key facts
| Inspection ID | 1203534 |
|---|---|
| Firm | Fenwal International, Inc. |
| FEI number | 3002806457 |
| Address | Parque Industrial Itabo Zona Franca Ind. De S.C, Carretera Sanchez Km 18 1/2 Bldgs. 48-50 |
| City | Bajos De Haina |
| Country | Dominican Republic (the) |
| Fiscal year | 2023 |
| Inspection end date | Apr 25, 2023 |
| 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