# FDA 483 - FUKUDA DENSHI CO., LTD. - Unknown Date

Source: https://www.keypedia.com/records/483/fukuda-denshi-co-ltd/1771812a-5bf8-4cfc-8dac-e9decc411428

> FDA 483 for FUKUDA DENSHI CO., LTD. on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FUKUDA DENSHI CO., LTD.
- Product Type: device
- Office Name: International Compliance Team
- Summary: An FDA inspection of Fukuda Denshi Co. Ltd., a medical device manufacturer in Tokyo, Japan, identified two significant observations. The firm was cited for inadequate documentation of Corrective and Preventive Action (CAPA) activities, including communication of updated instructions and adherence to internal procedures. Additionally, the Device History Record (DHR) procedure was found to be deficient as it did not require reassembly and rework records to be included.

## Related Officers

- [Melanie W. Ashinery](https://www.keypedia.com/people/melanie-w-ashinery/085cb59e-fc26-425e-bf59-d8ce0db7d210)

Company: https://www.keypedia.com/companies/fukuda-denshi-co-ltd/650eb780-1972-44b8-99eb-55d95bec36e2

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321