CYIENT DLM LTD. – FDA Inspection, Sep 10, 2026

Record Details

This FDA Inspection record concerns CYIENT DLM LTD., with an inspection on September 10, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: CYIENT DLM LTD.
Inspection Date: September 10, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Felix J. Marrero (Issuing Officer)

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ID · 8b7b7523-a256-4e84-baa3-56eca3fe2990

Inspection Facts

Inspection number: 1335040
FDA center: Medical Devices & Rad Health
Project area: Project Evaluation: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 4.2.4Document Control Procedure Inadequate
ISO 13485:2016 Clause 6.1(b)Resources for meeting regulatory and customer requirements not provided
ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented
ISO 13485:2016 Clause 7.5.8Product status identification was not maintained
ISO 13485:2016 Clause 8.3.1Nonconforming product not identified and controlled

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FDA Inspection

CYIENT DLM LTD.September 10, 2026