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 3013438665.
Observations7
Issue DateNovember 05, 2025
StatusNo Warning Letter
Establishment TypeOutsourcing Facility
Related Inspections3
Establishment Details
Firm
Fresenius Kabi Compounding, LLC
Location
Canton, Massachusetts, United States
FEI Number
3013438665
Establishment Type
Outsourcing Facility
Product Type
Drugs
Issue Date
November 05, 2025
Country
United States
Inspection History, 2018 to 2025
VAI2
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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