FDA 483 - Endonovo Therapeutics, Inc. - October 31, 2025

An FDA inspection of Endonovo Therapeutics, Inc., a medical device manufacturer in Woodland Hills, CA, was conducted from October 29 to October 31, 2025. The inspection resulted in the issuance of a Form FDA 483, detailing significant observations concerning the company's adherence to regulatory quality system requirements. The primary issues identified centered on the absence of adequately established quality system procedures. Specifically, the company lacked defined quality policies, plans, and objectives, as well as insufficient design controls for managing product development and changes. Furthermore, the firm had not established purchasing controls for contractors and suppliers, nor procedures for identifying and addressing personnel training needs within the quality system.

Another critical observation noted the absence of established procedures for receiving, reviewing, and evaluating product complaints, including events potentially subject to medical device reporting requirements. These findings indicate a systemic gap in Endonovo Therapeutics' quality management system. The company is responsible for implementing comprehensive corrective actions to address these observed deficiencies, ensuring full compliance with federal regulations governing medical device manufacturing.