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's procedures for design input were found to be inadequately established, specifically regarding a use scenario for the Quick-Fit Suction Liner System. Additionally, the firm's risk analysis was deemed inadequate due to insufficient definition of severity for potential injuries from medical device failures.