FDA WARNING_LETTER - Shandong Zibo Shanchuan Medical Instrument Co. Ltd. - October 27, 2011

FDA WARNING_LETTER for Shandong Zibo Shanchuan Medical Instrument Co. Ltd. on October 27, 2011. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Shandong Zibo Shanchuan Medical Instrument Co. Ltd. on October 27, 2011. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

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

21 CFR 803.17(a)

21 CFR 820.100(a)

21 CFR 820.30(i)

21 CFR 820.181(a)

21 CFR 820

21 CFR 820.72(a)

21 U.S.C. 321(h)

21 U.S.C. 381(a)

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Record Information

Company

Shandong Zibo Shanchuan Medical Instrument Co. Ltd.

Inspection Date

October 27, 2011

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: fc829caf-d18f-4f89-8485-e6eadcf2ce8a

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