FDA WARNING_LETTER - Okamoto Industries, Inc. - July 23, 2015

FDA WARNING_LETTER for Okamoto Industries, Inc. on July 23, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Okamoto Industries, Inc. on July 23, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.100(a)

21 CFR 820.70(c)

21 U.S.C. 321(h)

21 CFR 820.70(a)

21 CFR 820.75(a)

21 U.S.C. 351(h)

21 CFR 820.30(g)

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Record Information

Company

Okamoto Industries, Inc.

Inspection Date

July 23, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 582a7a9c-890b-439e-9a2b-207dddc76608

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