FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, Mar 30, 2017
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on March 30, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Erika E. Englund (Issuing Officer)
- Helen B. Ricalde (FDA Associated Person)
- Mindy M. Chou (FDA Associated Person)
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ID · fa80ae85-8005-43d6-9e43-13e92aa608d0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014707
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
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 |
| October 13, 2023 | VAI | Center for Drug Evaluation and Research | 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 |
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