FDA WARNING_LETTER - modern allergy management llc - June 16, 2020

FDA WARNING_LETTER for modern allergy management llc on June 16, 2020. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for modern allergy management llc on June 16, 2020. 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. 352(a)

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

modern allergy management llc

Inspection Date

June 16, 2020

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy Stenzel

ID: 014073b6-c604-4082-a7a5-8019b8fe06c2

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