483
Kaneka Corporation Tomatoh PlantKaneka Corporation Tomatoh Plant – FDA 483, Oct 18, 2024
Record Details
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.
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ID · 1834d69d-0f80-46a4-8d24-5d9f78bab32d
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