FDA WARNING_LETTER - Zoll Lifecor Corporation - June 20, 2014

FDA WARNING_LETTER for Zoll Lifecor Corporation on June 20, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Zoll Lifecor Corporation on June 20, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.100(b)

21 CFR 820.198(a)

21 CFR 820.20(c)

21 CFR 803.50(a)(2)

21 U.S.C. 351(h)

21 CFR 820.30(g)

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Record Information

Company

Zoll Lifecor Corporation

Inspection Date

June 20, 2014

Product Type

Devices

Office

Philadelphia District Office

People

Anne E. Johnson (Senior Science Advisor)

ID: c8da8803-2341-4a51-b501-081672753a09

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