FDA WARNING_LETTER - Health-Chem Diagnostics, LLC - February 03, 2017

FDA WARNING_LETTER for Health-Chem Diagnostics, LLC on February 03, 2017. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Health-Chem Diagnostics, LLC on February 03, 2017. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

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

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360bbb-3

21 U.S.C. 360e(a)

21 CFR 807.81(b)

21 U.S.C. 352(o)

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Record Information

Company

Health-Chem Diagnostics, LLC

Inspection Date

February 3, 2017

Product Type

Devices

Office

Florida District Office

People

Kathleen M. Sinninger

ID: 7959722b-299f-48a8-bd2e-2b799c45a64f

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