FDA WARNING_LETTER - Beckman Coulter, Inc. - May 12, 2011

FDA WARNING_LETTER for Beckman Coulter, Inc. on May 12, 2011. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Beckman Coulter, Inc. on May 12, 2011. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.52(f)(7)

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

21 CFR 803.52(e)(3)

21 CFR 820.25(b)

21 CFR 820.100(a)

21 CFR 820.30(i)

21 CFR 820

21 CFR 806.10(a)(1)

21 U.S.C. 321(h)

21 CFR 820.100(b)

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Record Information

Company

Beckman Coulter, Inc.

Inspection Date

May 12, 2011

Product Type

Devices

Office

Los Angeles District Office

People

Alonza E. Cruse (Director)

ID: 5119ba85-d26c-4464-a625-daa6854d5672

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