etectRX LLC. – FDA 483, Aug 1, 2025

An FDA inspection of etectRX LLC. in Gainesville, FL, revealed significant deficiencies in their quality system for medical device manufacturing. Observations included failures in production process controls, inadequate supplier qualification, improper complaint handling, and non-compliance with Unique Device Identifier (UDI) requirements for device labeling and database submission. These issues indicate a broad lack of adherence to established procedures and regulatory standards.