FDA inspection
Fresenius Kabi USA, LLC: FDA inspection ending Aug 8, 2025
FDA inspection 1278050 · Official Action Indicated (OAI) · North Andover, MA
Key facts
| Inspection ID | 1278050 |
|---|---|
| Firm | Fresenius Kabi USA, LLC |
| FEI number | 3014732157 |
| Address | 50 High St Ste 50 |
| City | North Andover |
| State | MA |
| ZIP | 01845 |
| Country | United States |
| Fiscal year | 2025 |
| Inspection end date | Aug 8, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
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