FDA WARNING_LETTER - NeuroTherm, Inc. - April 26, 2012

FDA WARNING_LETTER for NeuroTherm, Inc. on April 26, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for NeuroTherm, Inc. on April 26, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.30(i)

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.80(b)

21 CFR 820.70(a)

21 CFR 820.198(a)

21 U.S.C. 351(h)

21 CFR 820.30(j)

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Record Information

Company

NeuroTherm, Inc.

Inspection Date

April 26, 2012

Product Type

Devices

Office

New England District Office

People

ID: f0c6e9a1-232f-4cb9-858e-75383d4bceb7

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