FDA WARNING_LETTER - pomegranate consulting, llc, pomegranate consulting, ltd. - August 17, 2020

FDA WARNING_LETTER for pomegranate consulting, llc, pomegranate consulting, ltd. on August 17, 2020. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for pomegranate consulting, llc, pomegranate consulting, ltd. on August 17, 2020. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 331(a)

21 U.S.C. 331(k)

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

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

21 U.S.C. 352(o)

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Record Information

Company

pomegranate consulting, llc, pomegranate consulting, ltd.

Inspection Date

August 17, 2020

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy Stenzel

ID: 18a388c6-28f0-4371-8bab-1e75340b70eb

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