FDA Inspection 1037657 — Fresenius Medical Care Renal Therapies Group, LLC
The FDA completed an inspection of Fresenius Medical Care Renal Therapies Group, LLC on January 12, 2018 in Waltham, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 12, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Waltham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |