483
LEESAR, INCLEESAR, INC – FDA 483, Jul 18, 2025
Record Details
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.
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- Florida District Office
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ID · c12ff399-e032-40df-9af7-7b45fe5c016f
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