FDA WARNING_LETTER - Digitimer Ltd. - July 02, 2015

FDA WARNING_LETTER for Digitimer Ltd. on July 02, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Digitimer Ltd. on July 02, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.30(i)

21 CFR 820.70(c)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.90(b)(2)

21 CFR 820.181(d)

21 CFR 820.90(a)

21 U.S.C. 351(h)

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Record Information

Company

Digitimer Ltd.

Inspection Date

July 2, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 111f9aa1-eeff-41e5-9f3a-4469f5be4c95

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