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 3011688532.
Observations5
Issue DateFebruary 27, 2025
StatusNo Warning Letter
Establishment TypeOutsourcing Facility
Related Inspections4
Establishment Details
Firm
Eagle Pharma Outsourcing LLC
Location
Hoover, Alabama, United States
FEI Number
3011688532
Establishment Type
Outsourcing Facility
Product Type
Outsourcing Facility
Issue Date
February 27, 2025
Country
United States
Inspection History, 2015 to 2025
VAI2
OAI2
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
Talk to a Specialist