Hitachi High Tech America, Inc. Radiation Therapy Division – FDA 483, Mar 9, 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.
- Inspection date
- March 9, 2020
- Product type
- device
ID · da106fcb-4341-4993-9a47-c9cab8d52de2
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