FDA Inspection
Fresenius Medical Care Holdings, Inc.Fresenius Medical Care Holdings, Inc. – FDA Inspection, Oct 16, 2024
Record Details
This FDA Inspection record concerns Fresenius Medical Care Holdings, Inc., with an inspection on October 16, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · b5e4790b-ea64-4d4e-9ffd-f8cdd00f1eb1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1237243
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
Full citation text and observation details available on the Dashboard.
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 |
| August 2, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 2, 2019 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| 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 1214802 - 2023-08-02
- FDA Inspection 1098363 - 2019-08-02
- FDA Inspection 1037657 - 2018-01-12
- FDA Inspection 1051942 - 2017-10-19
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.