FDA 483 - Allstar Marketing Group Llc - March 11, 2026

Allstar Marketing Group Llc, an importer of Class II medical devices in Hawthorne, NY, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate supplier evaluation, failure to maintain risk management records, and a critical failure to report serious device-related injuries to the FDA within the required timeframe. The firm also lacked essential quality management system procedures and complaint handling documentation.