Amarin Corp Plc (AMRN)

[sts66]

You couldn't find evidence of FDA requiring a plant inspection prior to ANDA approval because there isn't any - postes just thinks it is - you should know better than to take him at his word. Some people also have claimed you need to prove you can make X amount of a generic drug for ANDA approval - that's also false. The FDA is totally over burdened with foreign plant inspections for companies that are already making drugs, let alone facilities for a new generic - so short handed sometimes there's many years in between inspections.