CARE LIVING DIAGNOSTICS INC – FDA Inspection, Jul 10, 2026

Record Details

This FDA Inspection record concerns CARE LIVING DIAGNOSTICS INC, with an inspection on July 10, 2026, issued by the New York District Office, covering medical devices & rad health.

Company: CARE LIVING DIAGNOSTICS INC
Inspection Date: July 10, 2026
Product Type: Medical Devices & Rad Health
Office: New York District Office
Person: Preston M. Lee (Investigator)

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ID · 862469a2-64a8-4080-b504-3e3779ba2946

Inspection Facts

Inspection number: 1326490
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.17Lack of Written MDR Procedures
ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
ISO 13485:2016 Clause 8.5.3Preventive action procedures not documented

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FDA Inspection

CARE LIVING DIAGNOSTICS INCJuly 10, 2026