FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, Feb 5, 2019
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on February 5, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 203bae6f-9223-4dfa-910b-8b1e26d5522d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079248
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Fresenius Kabi USA, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2026 | Not classified | Atlanta District Office | |
| February 8, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 13, 2023 | OAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| 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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