# FDA 483 - SHIBUYA CORPORATION - February 01, 2024

Source: https://www.keypedia.com/records/483/shibuya-corporation/1b992c12-0833-4850-a340-d6aedbab1d04

> FDA 483 for SHIBUYA CORPORATION on February 01, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SHIBUYA CORPORATION
- Inspection Date: 2024-02-01
- Product Type: device
- Office Name: International Compliance Team
- Summary: An FDA inspection of Shibuya Corporation, a device manufacturer in Kanazawa, Japan, revealed significant issues with their quality system. The firm failed to adequately establish procedures for Corrective and Preventive Action (CAPA) and did not properly control products that did not conform to specifications. These deficiencies indicate a need for improved quality management practices to ensure product safety and effectiveness.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/shibuya-corporation/2fca2811-f9fd-4380-bea5-0bdccfab5411

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