FDA 483 - Footprint Medical, Inc. - September 21, 2018

Footprint Medical, Inc. in San Antonio, TX, a medical device manufacturer, was inspected by the FDA and received a Form 483. The inspection revealed significant deficiencies in process validation, risk analysis, medical device reporting procedures, and production process controls for their Polyurethane Peripherally Inserted Central Catheter (PIIC) devices. These issues indicate a lack of adequate quality system implementation, potentially affecting device safety and efficacy.