FDA WARNING_LETTER - ReNovo, Inc. - May 18, 2023

FDA WARNING_LETTER for ReNovo, Inc. on May 18, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for ReNovo, Inc. on May 18, 2023. 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 820.70(c)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 CFR 820.90(a)

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

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

21 CFR 807.81(b)

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Record Information

Company

ReNovo, Inc.

Inspection Date

May 18, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: eba994c2-de71-4155-9f8a-a216ffda9c3b

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