ENTERASENSE LIMITED – FDA Inspection, Aug 7, 2026

Record Details

This FDA Inspection record concerns ENTERASENSE LIMITED, with an inspection on August 7, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: ENTERASENSE LIMITED
Inspection Date: August 7, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Jaro P. Perera (Issuing Officer)

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ID · 62a70b36-3243-4e4d-bc78-b06c012a44ed

Inspection Facts

Inspection number: 1330794
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
ISO 13485:2016 Clause 7.3.6Design and development verification not performed
ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
ISO 13485:2016 Clause 8.2.6Monitoring and measurement requirements of product characteristics are not met
ISO 13485:2016 Clause 8.3.1Nonconforming product not identified and controlled
ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented

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FDA Inspection

ENTERASENSE LIMITEDAugust 7, 2026