CARESONO TECHNOLOGY CO., LTD. – FDA Inspection, Aug 27, 2026

Record Details

This FDA Inspection record concerns CARESONO TECHNOLOGY CO., LTD., with an inspection on August 27, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: CARESONO TECHNOLOGY CO., LTD.
Inspection Date: August 27, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Esteban Beltran (Issuing Officer)

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ID · 431d9d85-85e6-4049-ada2-361aa3be8886

Inspection Facts

Inspection number: 1335068
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.50(a)(1)Report of Death or Serious Injury
ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
ISO 13485:2016 Clause 7.5.1Production controls not adequate
ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
ISO 13485:2016 Clause 8.2.4Objectivity and impartiality of internal audit process not ensured
ISO 13485:2016 Clause 8.5.2Corrective action records not maintained

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FDA Inspection

CARESONO TECHNOLOGY CO., LTD.August 27, 2026