483
Bemis Manufacturing Co.Bemis Manufacturing Co. – FDA 483, Aug 14, 2019
Record Details
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.
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ID · 1dd61197-4d9f-44c7-a239-7473136283c2
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