FDA 483 - LEESAR, INC - July 18, 2025

An FDA inspection of LEESAR, INC in Fort Myers, FL, a repackager/relabeler of Class II medical device EMS kits, revealed two significant observations. The firm failed to establish adequate procedures for management reviews of its quality system pertaining to these kits. Additionally, procedures for quality audits were not adequately established to cover the assembly and distribution of the medical devices.