# FDA 483 - Fukuda Denshi Co., Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/fukuda-denshi-co-ltd/73ec6c74-d96d-4b5d-9a72-bf0f1c845b7f

> 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, revealed significant deficiencies in their Corrective and Preventive Action (CAPA) procedures. The firm failed to adequately document CAPA effectiveness, maintain complete CAPA records, and initiate CAPAs for identified product issues. These findings indicate a lack of robust quality system controls.

## Related Documents

- [483 - 2000-12-08](https://www.keypedia.com/records/483/fukuda-denshi-co-ltd/987fb104-c008-4597-9735-8d2efcf7cb44)

## 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/3c7286c9-fc6f-4635-88a1-2a1b855410a0

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