FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, Oct 13, 2023
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on October 13, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a88e316f-f4c4-4146-b519-14affbebe818
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220482
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Fresenius Kabi USA, LLC
15| Date | Classification | Office | Project area |
|---|---|---|---|
| May 14, 2026 | Not classified | New York District Office | Drug Quality Assurance |
| August 30, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 12, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 29, 2018 | Not classified | New York District Office | |
| March 30, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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