Fresenius Kabi USA, LLC
FDA regulatory history for Fresenius Kabi USA, LLC: 55 Form 483s, 68 Recalls.
55Form 483s
0Warning Letters
68Recalls
123Total Actions
Jul 16, 2026Last Event
Total Actions = Form 483s + Warning Letters + Recalls.
GMP issues cited
- Investigations (7)
- Training Competency (4)
- Labeling Controls (1)
- Equipment Qualification (1)
- Aseptic Processing (1)
Facility types: Pharmaceutical
See the regulatory timeline, risk score, GMP issue radar, peer comparison, and document downloads on the 483 Signal dashboard.
This profile aggregates publicly available FDA documents and does not constitute an assessment of this company's compliance status. Companies may have taken corrective actions not yet reflected in public records. Provided for informational purposes only.