FDA Inspection
Fresenius Medical Care Deutschland GmbhFresenius Medical Care Deutschland Gmbh – FDA Inspection, May 2, 2023
Record Details
This FDA Inspection record concerns Fresenius Medical Care Deutschland Gmbh, with an inspection on May 2, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 93bbd2bd-6a7e-4343-bdac-aa724bf35e71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1205261
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Fresenius Medical Care Deutschland Gmbh
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 24, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 9, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fresenius Medical Care Deutschland Gmbh
- FDA Inspection 1290514 - 2023-06-29
- FDA Inspection 1204319 - 2020-06-24
- FDA Inspection 1017671 - 2017-06-09
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