FDA WARNING_LETTER - ProSun International, LLC - March 14, 2011

FDA WARNING_LETTER for ProSun International, LLC on March 14, 2011. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for ProSun International, LLC on March 14, 2011. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 U.S.C. 360j(g)

21 CFR 1004.1

21 CFR 1004.1(a)

21 CFR 820.30(a)

21 CFR 1040.20(c)(2)(iv)

21 CFR 820.25(b)

21 CFR 1002

21 U.S.C. 351(f)(1)(B)

21 CFR 1003.10(b)

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Record Information

Company

ProSun International, LLC

Inspection Date

March 14, 2011

Product Type

Devices

Office

Florida District Office

People

ID: 1e69d72a-0b75-4397-9527-cf604b861552

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