FDA 483 - LISI MEDICAL Remmele, Inc - July 12, 2022

LISI MEDICAL Remmele, Inc. in Coon Rapids, MN, a medical device manufacturer, was cited with two observations during an FDA inspection. The firm failed to adequately evaluate the impact on device quality when test/measurement equipment was found out of tolerance and did not establish clear procedures for acceptance activities, including inspection criteria and product release requirements. These issues indicate deficiencies in their quality system.