GREEN STERILIZATION CO., LTD. – FDA Inspection, Aug 12, 2026

Record Details

This FDA Inspection record concerns GREEN STERILIZATION CO., LTD., with an inspection on August 12, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: GREEN STERILIZATION CO., LTD.
Inspection Date: August 12, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: William R. Chang (Issuing Officer)

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ID · a8a52ab6-cd58-4cce-964f-7683be1796e9

Inspection Facts

Inspection number: 1330472
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 6.2(e)Records of personnel competence not maintained
ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
ISO 13485:2016 Clause 8.2.4Objectivity and impartiality of internal audit process not ensured

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FDA Inspection

GREEN STERILIZATION CO., LTD.August 12, 2026