FDA 483 - Agile Devices, Inc. - September 15, 2023

An FDA inspection of Agile Devices, Inc. in Newton Center, MA, from September 7-15, 2023, revealed significant deficiencies in the firm's quality management system. Observations included inadequate procedures for quality audits, lack of employee training documentation, failure to evaluate critical suppliers, and insufficient management review of the quality system. These findings indicate a systemic failure to establish and follow essential quality control processes for medical device manufacturing.