FDA 483 - Hitachi America, Ltd., Particle Therapy Division - March 09, 2020

Hitachi America, Ltd., Particle Therapy Division in Tarrytown, NY, a medical device manufacturer, was cited for deficiencies related to its complaint handling system. The inspection revealed issues with the completeness of complaint investigation records, particularly regarding patient injury determination and complainant contact information for safety-related incidents. Additionally, the firm's procedures for receiving and evaluating complaints lacked clear assignment of responsibilities across different Hitachi sites.