# Kaneka Corporation Tomatoh Plant – FDA 483, Oct 18, 2024

Source: https://www.keypedia.com/records/483/kaneka-corporation-tomatoh-plant/1834d69d-0f80-46a4-8d24-5d9f78bab32d

> FDA 483 for Kaneka Corporation Tomatoh Plant on October 18, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kaneka Corporation Tomatoh Plant
- Inspection Date: 2024-10-18
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Kaneka Corporation Tomatoh Plant in Tomakomai, Hokkaido, Japan, a medical device manufacturer, revealed significant deficiencies in its quality system. Observations included inadequate procedures for environmental control, complaint handling, and management review. Additionally, device history records lacked essential manufacturing parameters, indicating systemic issues in maintaining compliance.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/kaneka-corporation-tomatoh-plant/45342999-77b3-4212-ba33-aa5508d41056

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8