FDA WARNING_LETTER - Vevazz LLC - June 20, 2019

FDA WARNING_LETTER for Vevazz LLC on June 20, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Vevazz LLC on June 20, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 820.80(d)

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

21 CFR 820.90

21 CFR 807.81(a)(3)

21 CFR 820.25

21 U.S.C. 352(t)(2)

21 CFR 820.198

21 CFR 820.30

21 U.S.C. 352(a)

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Record Information

Company

Vevazz LLC

Inspection Date

June 20, 2019

Product Type

Devices

Office

Office of Medical Device and Radiological Health Operations (Division 1)

People

ID: a40071a7-a4a7-4736-83ab-0d8bf257a437

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