FDA WARNING_LETTER - OEM Systems Co., Ltd. - October 28, 2010

FDA WARNING_LETTER for OEM Systems Co., Ltd. on October 28, 2010. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for OEM Systems Co., Ltd. on October 28, 2010. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 820.90

21 CFR 820.250(b)

21 CFR 820.30(i)

21 CFR 820

21 CFR 820.100

21 U.S.C. 321(h)

21 U.S.C. 381(a)

21 CFR 820.75(a)

21 CFR 820.30(f)

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Record Information

Company

OEM Systems Co., Ltd.

Inspection Date

October 28, 2010

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Alberto Gutierrez (Director)

ID: 77f3c819-609a-423a-a923-8c7acf4fcbfe

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