Source: FDA, document on fileFDA 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 this against FDA, open FDA's record for this establishment on FDA's Data Dashboard, which lists this inspection under FEI 3011688532.
Eagle Pharma Outsourcing LLC
Hoover, Alabama, United States
Issue DateAugust 12, 2021
FEI Number3011688532
CountryUnited States
Status
No Warning Letter
Product Type
Outsourcing Facility
Establishment Type
Outsourcing Facility
Sub Systems Impacted
5
Area CleaningBatch RecordsContamination ControlEnvironmental MonitoringLaboratory Controls
Quality Systems
Facilities & EquipmentLaboratory ControlsProduction System
Eagle Pharma Outsourcing LLC FDA Form 483, Hoover, Alabama, August 12, 2021
