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'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.
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ID · 1191671e-0c42-45ff-baef-44a5c3e566ba
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