FDA Inspection 1098363 — Fresenius Medical Care Renal Therapies Group, LLC
The FDA completed an inspection of Fresenius Medical Care Renal Therapies Group, LLC on Aug 2, 2019 in Waltham, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 2, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Waltham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18026 | 21 CFR 314.80(f)(2) | Incomplete ADE information on ICSR |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |