FDA Inspection
Fresenius Medical Care, North AmericaFresenius Medical Care, North America – FDA Inspection, Mar 6, 2026
Record Details
This FDA Inspection record concerns Fresenius Medical Care, North America, with an inspection on March 6, 2026, issued by the Denver District Office, covering human drugs.
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ID · 8927a65e-c43b-4bfb-9545-02ae01310959
Inspection Facts
- Inspection number
- 1305990
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Fresenius Medical Care, North America
11| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2026 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 21, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 13, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 18, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 18, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fresenius Medical Care, North America
- FDA Inspection 1330254 - 2026-07-24
- FDA Inspection 1142311 - 2021-05-21
- FDA Inspection 1126818 - 2020-08-13
- FDA Inspection 1023304 - 2017-08-18
- FDA Inspection 1015295 - 2017-05-18
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