FDA WARNING_LETTER - APK Technology Co., Ltd. - February 03, 2015

FDA WARNING_LETTER for APK Technology Co., Ltd. on February 03, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for APK Technology Co., Ltd. on February 03, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.72(b)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.90(b)(2)

21 CFR 820.75(a)

21 CFR 820.80(e)

21 U.S.C. 351(h)

21 CFR 820.30(j)

21 CFR 820.70(g)

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Record Information

Company

APK Technology Co., Ltd.

Inspection Date

February 3, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Jan B. Welch

ID: 1bd21f64-9fcf-41fa-acc0-a952aa32cf7d

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