FDA Inspection
Kaneka Corporation Tomatoh PlantKaneka Corporation Tomatoh Plant – FDA Inspection, Oct 18, 2024
Record Details
This FDA Inspection record concerns Kaneka Corporation Tomatoh Plant, with an inspection on October 18, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- October 18, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · a1d936d7-1be0-46c8-9bf8-dc270267ba3f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1253979
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
4- 21 CFR 820.184DHR content
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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