FDA WARNING_LETTER - Longhorn Vaccines And Diagnostics LLC - October 30, 2025

FDA WARNING_LETTER for Longhorn Vaccines And Diagnostics LLC on October 30, 2025. Product: devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Longhorn Vaccines And Diagnostics LLC on October 30, 2025. Product: devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.198(a)

21 CFR 820.100(a)

21 CFR 820.30(a)

21 CFR 803.17

21 CFR 820

21 CFR 820.100(a)(4)

21 CFR 820.90(a)

21 CFR 820.22

21 CFR 803

21 CFR 807.81(a)(3)(ii)

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Record Information

Company

Longhorn Vaccines And Diagnostics LLC

Inspection Date

October 30, 2025

Product Type

devices

Office

Office of Regulatory Programs

People

ID: f4953f9e-6c53-455c-86f5-014bceef80c7

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