FDA issues third warning letter to Olympus for failure to rectify endoscope complaints

The FDA has issued a warning letter to Olympus Medical over their manufacturing of endoscopes and endoscope accessories following an inspection of their Tokyo facility in Japan.This is the third warning letter from the FDA following two separate letters issued to Olympus at the end of 2022.According to the letter, the inspection which occurred Nov. 7, 2022, through Nov. 10, 2022, revealed that the devices were “adulterated,” meaning the methods, facilities or controls used for, their manufacture, packing, storage, or installation were not “in conformity with the current goodRead More