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 3011536648.
Option Care
San Antonio, Texas, United States
Issue DateAugust 18, 2015
FEI Number3011536648
CountryUnited States
Status
No Warning Letter
Product Type
Drugs
Establishment Type
Producer of Sterile Drug Products
Sub Systems Impacted
4
Area CleaningContamination ControlEnvironmental MonitoringStability Studies
Quality Systems
Facilities & EquipmentLaboratory ControlsProduction System
Option Care FDA Form 483, San Antonio, Texas, August 18, 2015
