Source: FDA record for this establishment. FDA publishes inspections or enforcement actions for this establishment, listed further down this page, but we have not matched this particular Form 483 to a document or an inspection date FDA has released. It stays out of the default view for that reason. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1450022.
ObservationsNot available
Issue DateFebruary 18, 2026
Status1 Related Warning Letter
Establishment TypeSterile Drug Manufacturer
Related Inspections10
Establishment Details
Firm
Fresenius Kabi USA LLC
Location
Illinois
FEI Number
1450022
Establishment Type
Sterile Drug Manufacturer
Issue Date
February 18, 2026
Country
United States
Inspection History, 2011 to 2023
NAI6
VAI2
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.