FDA Inspection
Fresenius Medical Care Holdings, Inc.Fresenius Medical Care Holdings, Inc. – FDA Inspection, Aug 2, 2019
Record Details
This FDA Inspection record concerns Fresenius Medical Care Holdings, Inc., with an inspection on August 2, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8bd78b13-d6f0-47ce-8ed2-54a981660155
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1098363
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(f)(2)Incomplete ADE information on ICSR
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Other FDA inspections of Fresenius Medical Care Holdings, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2026 | Not classified | New England District Office | Compliance: Devices |
| October 16, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 2, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 12, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 19, 2017 | Not classified | New England District Office |
Other documents for Fresenius Medical Care Holdings, Inc.
- FDA Inspection 1322950 - 2026-06-03
- FDA Inspection 1237243 - 2024-10-16
- FDA Inspection 1214802 - 2023-08-02
- FDA Inspection 1037657 - 2018-01-12
- FDA Inspection 1051942 - 2017-10-19
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