FDA WARNING_LETTER - Hoya Corporation - Pentax Life Division - April 24, 2015

FDA WARNING_LETTER for Hoya Corporation - Pentax Life Division on April 24, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Hoya Corporation - Pentax Life Division on April 24, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 803.3

21 CFR 820.100(a)

21 CFR 803.50(a)

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 803.40

21 CFR 803

21 CFR 820.75(a)

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Record Information

Company

Hoya Corporation - Pentax Life Division

Inspection Date

April 24, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 3eccb8e9-22b4-45b8-9a2a-c2a2ce5bbc91

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