FDA 483 - Ambco Electronics, Incorporated - October 15, 2021

Ambco Electronics, Incorporated in Tustin, CA, a manufacturer of Class II audiometric devices, was cited for failing to establish a complete design history file (DHF) for its 1000+ and 1000+ P product lines. This critical omission means the firm lacks documentation demonstrating proper design development, including design review, verification, validation, software validation, and risk analysis, as required by their own procedures and regulatory standards. This is a significant quality system deficiency impacting product safety and effectiveness.