Enterra Medical, Inc. – FDA Inspection, May 4, 2026

Record Details

This FDA Inspection record concerns Enterra Medical, Inc., with an inspection on May 4, 2026, issued by the Minneapolis District Office, covering medical devices & rad health.

Company: Enterra Medical, Inc.
Inspection Date: May 4, 2026
Product Type: Medical Devices & Rad Health
Office: Minneapolis District Office
Person: Tyler R. Courtney (Company Rep)

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ID · 99be41a6-da84-4dba-bdc2-44583b84d4a1

Inspection Facts

Inspection number: 1315766
FDA center: Medical Devices & Rad Health
Project area: Project Evaluation: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
ISO 13485:2016 Clause 7.3.9Review of design and development do not include evaluation of change effects
ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated

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FDA Inspection

Enterra Medical, Inc.May 4, 2026