UNIBELL SRL – FDA Inspection, Sep 10, 2026

Record Details

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

Company: UNIBELL SRL
Inspection Date: September 10, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: John A. Sciacchitano (Company Rep)

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ID · 77c4a8b6-a6de-48ac-b2fa-a16777472c0f

Inspection Facts

Inspection number: 1335056
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 5.6.3Management review output records lack input reviewed, decisions, and actions
ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
ISO 13485:2016 Clause 8.2.6Monitoring and measurement requirements of product characteristics are not met

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FDA Inspection

UNIBELL SRLSeptember 10, 2026