FDA 483 - LISI MEDICAL Remmele, Inc - May 01, 2025

LISI MEDICAL Remmele, Inc. in Coon Rapids, MN, a medical device manufacturer, was cited for two significant issues during an FDA inspection. The firm's procedures for corrective and preventive actions were found inadequate, failing to ensure the verification or validation of action effectiveness. Additionally, the company's training procedures did not consistently identify essential training needs or ensure employees were properly trained for their assigned responsibilities, including critical quality inspection roles.