FDA 483 - My Medical Store LLC - December 18, 2025

My Medical Store LLC in Fort Lauderdale, FL, an initial importer and own label distributor of Class I surgical instruments, received a Form FDA-483 with four observations. The inspection revealed significant breakdowns in the firm's quality system, including issues with document control, medical device reporting procedures, supplier management, and incoming product acceptance. These deficiencies represent serious compliance gaps that could compromise product quality and patient safety.