FDA Inspection
Fresenius Medical Care Holdings, Inc.Fresenius Medical Care Holdings, Inc. – FDA Inspection, Jun 3, 2026
Record Details
This FDA Inspection record concerns Fresenius Medical Care Holdings, Inc., with an inspection on June 3, 2026, issued by the New England District Office, covering medical devices & rad health.
- Inspection Date
- June 3, 2026
- Product Type
- Medical Devices & Rad Health
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ID · ee34cb87-4b07-435e-8483-eb8a9e986ebc
Inspection Facts
- Inspection number
- 1322950
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.3.6Design and development verification plans not documented
- ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product
- ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
- ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of Fresenius Medical Care Holdings, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2024 | OAI | Center for Devices and Radiological Health | 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 1237243 - 2024-10-16
- FDA Inspection 1214802 - 2023-08-02
- FDA Inspection 1098363 - 2019-08-02
- FDA Inspection 1037657 - 2018-01-12
- FDA Inspection 1051942 - 2017-10-19
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