FDA Inspection 1310976 - Oak Ridge Products - April 01, 2026

FDA Inspection 1310976 for Oak Ridge Products on April 01, 2026. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1310976 for Oak Ridge Products on April 01, 2026. Classification: Voluntary Action Indicated (VAI).

Violation Codes

ISO 13485:2016 Clause 5.6.1

ISO 13485:2016 Clause 7.3.9

ISO 13485:2016 Clause 7.5.8

ISO 13485:2016 Clause 8.2.2

ISO 13485:2016 Clause 8.2.4

ISO 13485:2016 Clause 8.3.1

ISO 13485:2016 Clause 8.5.2

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Record Information

Company

Oak Ridge Products

Inspection Date

April 1, 2026

Product Type

Medical Devices & Rad Health

Office

Center for Devices and Radiological Health

ID: ef8966f6-dd54-4d51-a4ed-900943849f5d

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