FDA WARNING_LETTER - Guilin Zizhu Latex Co., Ltd - March 07, 2015

FDA WARNING_LETTER for Guilin Zizhu Latex Co., Ltd on March 07, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Guilin Zizhu Latex Co., Ltd on March 07, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.30(a)

21 CFR 820.72(a)

21 U.S.C. 321(h)

21 CFR 820.90(a)

21 U.S.C. 381(a)

21 CFR 820.75(a)

21 U.S.C. 351(h)

21 CFR 820.70(i)

21 CFR 820.70(e)

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Record Information

Company

Guilin Zizhu Latex Co., Ltd

Inspection Date

March 7, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Jan B. Welch

ID: 52c054ef-e5c3-4ef7-ab05-c36644491036

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