FDA 483 - AEI Technologies, Inc - November 16, 2023

AEI Technologies, Inc. in Bastrop, TX, a medical device manufacturer, was inspected and received a Form FDA 483 with seven observations. The inspection revealed significant deficiencies in quality system documentation, including inadequate process and software validation, insufficient UDI labeling and GUDID registration, and poor record-keeping for nonconforming product rework, supplier management, and employee training. These issues indicate a systemic lack of adherence to regulatory requirements for medical device manufacturing.