FDA inspection
Fresenius Medical Care Renal Therapies Group, LLC: FDA inspection ending Oct 16, 2024
FDA inspection 1237243 · Official Action Indicated (OAI) · Waltham, MA
Key facts
| Inspection ID | 1237243 |
|---|---|
| Firm | Fresenius Medical Care Renal Therapies Group, LLC |
| FEI number | 3001451489 |
| Address | 920 Winter St Bld 920 |
| City | Waltham |
| State | MA |
| ZIP | 02451 |
| Country | United States |
| Fiscal year | 2025 |
| Inspection end date | Oct 16, 2024 |
| 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
- 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