FDA WARNING_LETTER - Randox Laboratories Limited - August 08, 2024

FDA WARNING_LETTER for Randox Laboratories Limited on August 08, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Randox Laboratories Limited on August 08, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 351(h)

21 CFR 820.30(g)

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Record Information

Company

Randox Laboratories Limited

Inspection Date

August 8, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: bb21fada-ef96-4563-9c3d-f88cb02cf12e

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