FDA 483 - Footprint Medical, Inc. - March 26, 2026

An FDA inspection of Footprint Medical, Inc. in San Antonio, TX, from March 23-26, 2026, revealed a significant deficiency in their quality system. The firm failed to establish written quality agreements for outsourced processes that affect the conformity of their Class II Peripherally Inserted Central Catheters (PICC) to requirements. This indicates a lack of adequate control over critical suppliers for components like tubing, steel rods, and sterile pouches.