FDA 483 - Hospi Corporation - March 14, 2025

An FDA inspection of Hospi Corporation in San Mateo, CA, revealed significant deficiencies in the firm's quality system. The company failed to adequately establish and implement procedures for complaint handling, resulting in insufficient investigations into product defects for Macy catheters. Additionally, Hospi Corporation did not submit a required Medical Device Report (MDR) within 30 days for a serious adverse event involving a patient infection.