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

Source: https://www.keypedia.com/records/483/hitachi-america-ltd-particle-therapy-division/da106fcb-4341-4993-9a47-c9cab8d52de2

> FDA 483 for Hitachi America, Ltd., Particle Therapy Division on March 09, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hitachi America, Ltd., Particle Therapy Division
- Inspection Date: 2020-03-09
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Officers

- [Gregson A Joseph](https://www.keypedia.com/people/gregson-a-joseph/90bf8118-3f32-4f44-95c4-fcde1f741a18)

Company: https://www.keypedia.com/companies/hitachi-america-ltd-particle-therapy-division/e0123e20-f7aa-401a-a40c-79518c8b0ee8

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961