FDA WARNING_LETTER - Brava, LLC - March 14, 2014

FDA WARNING_LETTER for Brava, LLC on March 14, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Brava, LLC on March 14, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 812.40

21 CFR 812

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

21 CFR 812.150(b)(8)

21 CFR 812.150(b)(10)

21 U.S.C. 321(h)

21 CFR 812.46(a)

21 CFR 54.1(b)

21 CFR 812.150(b)(2)

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Record Information

Company

Brava, LLC

Inspection Date

March 14, 2014

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Steven D. Silverman (President)

ID: 719f0e52-9802-4cb2-a446-1b94e09af59a

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