FDA 483 - Bemis Manufacturing Co. - August 14, 2019

An FDA inspection of Bemis Manufacturing Co. in Sheboygan Falls, WI, a medical device manufacturer, revealed two significant observations. The firm failed to adequately establish procedures for design input, specifically omitting a critical use scenario for their Quick-Fit Suction Liner System. Additionally, their risk analysis was found to be inadequate due to a lack of defined severity for potential injuries from device failures.