FDA 483 - Aquila Corporation - December 07, 2023

Aquila Corporation, a medical device manufacturer in Holmen, WI, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, a failure to properly establish and implement complaint handling, and a complete lack of risk analysis for its SofTech Seating System. Additionally, the firm failed to include unique device identifiers (UDI) on its SofTech Seating System labels and did not submit UDI information to the GUDID.