The U.S. Food and Drug Administration (FDA) recently issued a warning letter to a Japan-based company that makes Class I and II non-sterile laser devices used for eye surgery. According to the letter, a May 2013 inspection of Nidek Co. Ltd.’s Aichi facility led to a finding that its devices are “adulterated . . . in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements” of 21 C.F.R. Part 820. Among the other purported violations is an apparent inadequate final inspection procedure that “allows the technician performing the final inspections to decide whether or not to perform some of the final inspection tests. . . . The procedure does not require the technician performing the final inspection to indicate whether the results were copied or actually performed by the technician at the final inspection.”