Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1450022.
Observations6
Issue DateMay 18, 2020
Status1 Related Warning Letter
Establishment TypeDrug Manufacturer
Related Inspections10
Establishment Details
Firm
Fresenius Kabi USA LLC
Location
Melrose Park, Illinois, United States
FEI Number
1450022
Establishment Type
Drug Manufacturer
Product Type
Drugs
Issue Date
May 18, 2020
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.
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