FDA inspection
Fresenius Medical Care Renal Therapies Group, LLC: FDA inspection ending Aug 2, 2023
FDA inspection 1214802 · Official Action Indicated (OAI) · Waltham, MA
Key facts
| Inspection ID | 1214802 |
|---|---|
| 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 | 2023 |
| Inspection end date | Aug 2, 2023 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 666791 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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