FDA WARNING_LETTER - Beckman Coulter, Inc. - June 02, 2011

FDA WARNING_LETTER for Beckman Coulter, Inc. on June 02, 2011. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Beckman Coulter, Inc. on June 02, 2011. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

FD&C Act 501(h)

21 CFR 820.25(b)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(a)

21 CFR 803

21 CFR 803.50(a)(2)

21 U.S.C. 351(h)

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Record Information

Company

Beckman Coulter, Inc.

Inspection Date

June 2, 2011

Product Type

Devices

Office

Department of Health and Human Services

People

ID: 1cd3da3d-4c0e-4104-92ce-6e3cefbd5926

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