FDA WARNING_LETTER - Omron Healthcare, Inc. - February 16, 2007

FDA WARNING_LETTER for Omron Healthcare, Inc. on February 16, 2007. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Omron Healthcare, Inc. on February 16, 2007. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.40(b)

21 CFR 820.50(a)

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

21 CFR 820.198(e)(5)

21 CFR 806.10(c)(4)

21 CFR 820.198(e)(7)

21 CFR 803.20(c)(2)

21 CFR 820.100(a)

21 CFR 820.20(b)(3)

21 CFR 820.40(a)

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Record Information

Company

Omron Healthcare, Inc.

Inspection Date

February 16, 2007

Product Type

Devices

Office

Chicago District Office

People

ID: c3ef70c4-39a6-42b5-9542-1a91593fb8fe

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