FDA WARNING_LETTER - Innova - July 11, 2024

FDA WARNING_LETTER for Innova on July 11, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Innova on July 11, 2024. 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 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 381(a)

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

21 CFR 820.198(a)

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

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

21 U.S.C. 352(o)

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Record Information

Company

Innova

Inspection Date

July 11, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: ff976c71-95bf-4440-85e6-cbf6407b1bc1

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