FDA WARNING_LETTER - Paragon Dx, LLC - August 19, 2009

FDA WARNING_LETTER for Paragon Dx, LLC on August 19, 2009. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Paragon Dx, LLC on August 19, 2009. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 864.4020(a)

21 CFR 864.4020(b)(1)

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

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 CFR 809.30(d)(4)

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

21 CFR 807.81(b)

21 U.S.C. 352(o)

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Record Information

Company

Paragon Dx, LLC

Inspection Date

August 19, 2009

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Alberto Gutierrez (Director)

ID: c3e3bea4-6ad2-44b4-842d-a11b35cb8aaa

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