The FDA would have been inspecting the plant when

The FDA would have been inspecting the plant when the product was originally made and data for the BLA would have been provided by Samsung not Amarex so a hold on production would not invalidate the the BLA submission or cause a clinical hold. It also wouldn't be lack of product because almost 12% of current stocks are good for two tears or more. With the rest of the stock it can be tested periodically after expiration for viability and expiration may be extended.