FDA 483 - Footprint Medical, Inc. - June 14, 2023

An FDA inspection of Footprint Medical, Inc. in San Antonio, TX, revealed significant quality system deficiencies. The firm failed to validate critical manufacturing processes, control production to meet device specifications, and adequately establish procedures for CAPA, design verification, and design transfer. Additional issues included unvalidated software, untrained audit personnel, and a lack of established statistical techniques for process control.