FDA WARNING_LETTER - Shima Laboratories Co., Ltd. - October 03, 2013

FDA WARNING_LETTER for Shima Laboratories Co., Ltd. on October 03, 2013. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Shima Laboratories Co., Ltd. on October 03, 2013. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.100(a)(1)

21 CFR 820.70(a)

21 CFR 820.198(a)

21 CFR 820.20(c)

21 CFR 803

21 CFR 820.75(a)

21 U.S.C. 351(h)

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Record Information

Company

Shima Laboratories Co., Ltd.

Inspection Date

October 3, 2013

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Alberto Gutierrez (Director)

ID: f0cec3c2-9f54-4478-8824-ba07b706c4c6

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