FDA WARNING_LETTER - Medsource, Inc. - March 31, 2015

FDA WARNING_LETTER for Medsource, Inc. on March 31, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Medsource, Inc. on March 31, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 360j(f)(1)(A)

21 U.S.C. 360c(f)

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

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

21 CFR 807.81(a)(3)(ii)

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Record Information

Company

Medsource, Inc.

Inspection Date

March 31, 2015

Product Type

Devices

Office

New England District Office

People

Amber G. Wardwell (Compliance Officer)

ID: 93cde4f4-39b3-4d9a-91e3-e30f36519c91

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