FDA WARNING_LETTER - CORIN MEDICAL, LTD. - March 05, 2015

FDA WARNING_LETTER for CORIN MEDICAL, LTD. on March 05, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for CORIN MEDICAL, LTD. on March 05, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.80(d)

21 CFR 820.90(b)

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

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.75(a)

21 CFR 820.30(f)

21 CFR 820.80(e)

21 CFR 803.50(a)(2)

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Record Information

Company

CORIN MEDICAL, LTD.

Inspection Date

March 5, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Jan B. Welch

ID: d99038b4-80a4-4e2c-8b75-13c4e211558a

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