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 3005531475.
Ophtapharm AG
Winterthur, -, Switzerland
Issue DateDecember 12, 2017
FEI Number3005531475
CountrySwitzerland
Status
No Warning Letter
Product Type
Drugs
Establishment Type
Finished Pharmaceutical Manufacturer
Sub Systems Impacted
4
Area CleaningCleaning ValidationSample TestingStability Studies
Quality Systems
Facilities & EquipmentLaboratory ControlsProduction System
Ophtapharm AG FDA Form 483, Winterthur, December 12, 2017
