Footprint Medical, Inc.June 14, 2023

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

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Record Details

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.

Company: Footprint Medical, Inc.
Inspection Date: June 14, 2023
Product Type: Device
Office: Division of Human and Animal Food Operations - West III
Person: Jocelyn C. Turner

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ID · 4628155f-390f-493c-a5ae-df8e53d5c3e6