NATERA, INc – FDA Inspection, Apr 6, 2026

Record Details

This FDA Inspection record concerns NATERA, INc, with an inspection on April 6, 2026, issued by the Dallas District Office, covering medical devices & rad health.

Company: NATERA, INc
Inspection Date: April 6, 2026
Product Type: Medical Devices & Rad Health
Office: Dallas District Office
Person: Katlin N. Stubbs

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ID · e1fe74d3-c4bc-4b7c-a0a1-6511070f37ad

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1311222
FDA center: Medical Devices & Rad Health
Project area: Project Evaluation: Devices
Outcome: Form 483 issued

FDA Citations

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

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FDA Inspection

NATERA, INcApril 6, 2026