FDA Inspection 1334114 - Opus KSD, Inc. - September 03, 2026

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Record Details

This FDA Inspection record concerns Opus KSD, Inc., with an inspection on September 3, 2026, issued by the Center for Devices and Radiological Health, covering devices.

Company: Opus KSD, Inc.
Inspection Date: September 3, 2026
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 316d99be-f595-4a52-b463-af6aa6e43aa1

Violation Codes2

ISO 13485:2016 Clause 4.1.3ISO 13485:2016 Clause 8.2.2

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