GENIAL DAY INC – FDA 483, Aug 3, 2021

GENIAL DAY INC, an initial importer/distributor and repackager in Orland Park, IL, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, specifically the complete absence of established procedures for complaint handling, medical device reporting, general quality system operations, acceptance activities, and corrective and preventive actions. These findings indicate a fundamental lack of control over critical aspects of medical device quality and regulatory compliance.