FDA WARNING_LETTER - Adventure Innovations LLC - August 07, 2024

FDA WARNING_LETTER for Adventure Innovations LLC on August 07, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Adventure Innovations LLC on August 07, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 807.81(b)(1)

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

21 CFR 807.81(a)(1)

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

Adventure Innovations LLC

Inspection Date

August 7, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Binita S. Ashar (Director)

ID: f5c39b04-cbf1-4d68-ad3d-7d8d622b2bee

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