FDA 483 - LISI MEDICAL Remmele, Inc - April 27, 2023

LISI MEDICAL Remmele, Inc. in Big Lake, MN, was inspected from April 24-27, 2023, and received one observation. The inspection revealed that the firm's procedures for controlling non-conforming product were not adequately established or followed. Specifically, the firm failed to obtain required Material Review Board (MRB) authorizations prior to disposition actions for multiple non-conformance reports.