FDA WARNING_LETTER - BioModeling Solutions, Inc. - September 11, 2017

FDA WARNING_LETTER for BioModeling Solutions, Inc. on September 11, 2017. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for BioModeling Solutions, Inc. on September 11, 2017. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.30(a)

21 CFR 820.25(b)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(a)

21 CFR 803

21 U.S.C. 351(h)

21 U.S.C. 360i

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Record Information

Company

BioModeling Solutions, Inc.

Inspection Date

September 11, 2017

Product Type

Devices

Office

Los Angeles District Office

People

Shari J. Shambaugh (Program Division Director)

ID: 1e4ff616-3eda-4fb2-ad84-a704b9cf5ab2

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