FDA WARNING_LETTER - Primus Corporation dba Trinity Biotech - February 06, 2020

FDA WARNING_LETTER for Primus Corporation dba Trinity Biotech on February 06, 2020. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Primus Corporation dba Trinity Biotech on February 06, 2020. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

21 U.S.C. 351(f)(1)(B)

21 CFR 820.30(i)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

21 CFR 807.81(a)(3)(i)

21 CFR 807.81(b)

21 CFR 820.30(f)

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Record Information

Company

Primus Corporation dba Trinity Biotech

Inspection Date

February 6, 2020

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 20468464-6d2d-4c66-a80d-b02394382ec7

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