FDA Inspection 1288376 - IRAY IMAGING LLC - October 24, 2025

FDA Inspection 1288376 for IRAY IMAGING LLC on October 24, 2025. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1288376 for IRAY IMAGING LLC on October 24, 2025. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 820.100(a)

21 CFR 820.30(h)

21 CFR 820.80(b)

21 CFR 820.90(a)

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Record Information

Company

IRAY IMAGING LLC

Inspection Date

October 24, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: b6936d63-71de-4923-8954-d81db8b9d87c

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