FDA WARNING_LETTER - Zeller Power Products, LLC - November 09, 2018

FDA WARNING_LETTER for Zeller Power Products, LLC on November 09, 2018. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Zeller Power Products, LLC on November 09, 2018. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 801 Sub B

21 U.S.C. 331(q)(1)(B)

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

21 CFR 820.30(a)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 352(c)

21 CFR 830

21 CFR 820.90(a)

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Record Information

Company

Zeller Power Products, LLC

Inspection Date

November 9, 2018

Product Type

Devices

Office

Division of Medical Device and Radiological Health Operations East

People

ID: 116b5408-154a-4eb3-ba68-1632d407c0e4

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