FDA WARNING_LETTER - Prodimed SAS - July 02, 2015

FDA WARNING_LETTER for Prodimed SAS on July 02, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Prodimed SAS on July 02, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.80(d)

21 CFR 820.100(a)

21 CFR 820.70(c)

21 U.S.C. 321(h)

21 U.S.C. 381(a)

21 CFR 820.75(a)

21 U.S.C. 351(h)

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Record Information

Company

Prodimed SAS

Inspection Date

July 2, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Sean M. Boyd (Office Director)

ID: 43de91bd-c7d9-4640-8afa-10cd086d067f

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