FDA WARNING_LETTER - Amplicon Land, LLC - May 17, 2021

FDA WARNING_LETTER for Amplicon Land, LLC on May 17, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Amplicon Land, LLC on May 17, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 331(a)

21 U.S.C. 331(k)

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

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

21 U.S.C. 352(o)

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Record Information

Company

Amplicon Land, LLC

Inspection Date

May 17, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy T. Stenzel (Director)

ID: ee6ed237-b12f-4de3-be5c-f2641ccbc36b

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