FDA 483 - AEI Technologies, Inc - January 29, 2025

AEI Technologies, Inc. in Bastrop, TX, was inspected and received a Form FDA 483 with three observations, two of which were repeats. The inspection revealed significant deficiencies in process validation for medical device test methods, inadequate documentation and timely closure of corrective and preventive actions (CAPAs), and poorly established procedures for handling rework of nonconforming products. These issues indicate a systemic breakdown in the firm's quality system.