FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, Aug 30, 2023
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on August 30, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7f0cd17c-920d-421e-8b7c-c5256d920e67
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1216357
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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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 |
| October 13, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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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