FDA Inspection
KANEKA MEDIX CORPORATION KANAGAWA PLANTKANEKA MEDIX CORPORATION KANAGAWA PLANT – FDA Inspection, Jan 30, 2025
Record Details
This FDA Inspection record concerns KANEKA MEDIX CORPORATION KANAGAWA PLANT, with an inspection on January 30, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- January 30, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 2306dcff-e956-4857-a9b2-0f417094e3f8
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1259483
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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