FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, Sep 7, 2023
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on September 7, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d1d35133-ab0a-4318-8ebc-ce736b2a6f9d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1217750
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Fresenius Kabi USA, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2025 | OAI | Compliance: Devices | |
| March 18, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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