Arjo Dominican Republic – FDA Inspection, May 28, 2026

Record Details

This FDA Inspection record concerns Arjo Dominican Republic, with an inspection on May 28, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Arjo Dominican Republic
Inspection Date: May 28, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Maryam Tabatabaie (Company Rep)

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ID · d83f676b-6924-4494-8535-6e3fc7c14098

Inspection Facts

Inspection number: 1319304
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product
ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated

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FDA Inspection

Arjo Dominican RepublicMay 28, 2026