FDA Inspection
Fresenius Kabi USA LLCFresenius Kabi USA LLC – FDA Inspection, Mar 18, 2009
Record Details
This FDA Inspection record concerns Fresenius Kabi USA LLC, with an inspection on March 18, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fresenius Kabi USA LLC
- Inspection Date
- March 18, 2009
- Product Type
- Drugs
View Company Profile
ID · 97586507-93bf-4195-928b-d61a04926ae3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 569783
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
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Other FDA inspections of Fresenius Kabi USA LLC
14| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2026 | Not classified | Chicago District Office | |
| August 24, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 30, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 18, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 3, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Fresenius Kabi USA LLC
- FDA Inspection 1311592 - 2026-02-18
- FDA Inspection 1216183 - 2023-08-24
- FDA Inspection 1174894 - 2022-06-30
- FDA Inspection 1123748 - 2020-05-18
- FDA Inspection 1075139 - 2018-12-03
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