FDA WARNING_LETTER - Hand Biomechanics Lab Inc - July 05, 2017

FDA WARNING_LETTER for Hand Biomechanics Lab Inc on July 05, 2017. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Hand Biomechanics Lab Inc on July 05, 2017. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.75

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

21 CFR 803.3

21 CFR 803.50(a)(1)

21 CFR 820

21 CFR 820.100

21 U.S.C. 321(h)

21 CFR 803

21 U.S.C. 351(h)

21 U.S.C. 360i

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Record Information

Company

Hand Biomechanics Lab Inc

Inspection Date

July 5, 2017

Product Type

Devices

Office

Los Angeles District Office

People

Kelly D. Sheppard (Director, Compliance Branch)

ID: 59c15b77-be8f-431d-9243-2727f8c98764

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