FDA WARNING_LETTER - Synovo Production, Inc. - October 26, 2022

FDA WARNING_LETTER for Synovo Production, Inc. on October 26, 2022. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Synovo Production, Inc. on October 26, 2022. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 812

21 U.S.C. 360(j)

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

21 CFR 807.81(a)(3)

21 U.S.C. 360(p)

21 CFR 820.30(a)

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

21 CFR 820.100(a)

21 CFR 820

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Record Information

Company

Synovo Production, Inc.

Inspection Date

October 26, 2022

Product Type

Devices

Office

Division of Medical Device and Radiological Health Operations East

People

ID: 961d8849-6eb5-46a2-89bc-38e90950e744

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