The FDA would have been inspecting the plant when the product was originally made and data for the BLA would have been provided by Samsung not Amarex so a hold on production would not invalidate the the BLA submission or cause a clinical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.