FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, Feb 8, 2024
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on February 8, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 0d2c4406-a247-4fb1-b873-9ef934f41f8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1229851
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
Other FDA inspections of Fresenius Kabi USA, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2026 | Not classified | Atlanta District Office | |
| June 13, 2023 | OAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| February 5, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 18, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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