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

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Record Details

This FDA Inspection record concerns Oak Ridge Products, with an inspection on April 1, 2026, issued by the Center for Devices and Radiological Health, covering devices.

Company: Oak Ridge Products
Inspection Date: April 1, 2026
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · e01a1509-9f52-4d0b-9dc9-db52d1e2daca

Violation Codes7

ISO 13485:2016 Clause 5.6.1ISO 13485:2016 Clause 7.3.9ISO 13485:2016 Clause 7.5.8ISO 13485:2016 Clause 8.2.2ISO 13485:2016 Clause 8.2.4ISO 13485:2016 Clause 8.3.1ISO 13485:2016 Clause 8.5.2

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