FDA WARNING_LETTER - CooperSurgical, Inc. - December 17, 2014

FDA WARNING_LETTER for CooperSurgical, Inc. on December 17, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for CooperSurgical, Inc. on December 17, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

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

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

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

21 CFR 807.81(a)(3)(ii)

21 CFR 807.81(b)

21 CFR 890.5710

21 CFR 803.50(a)(2)

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Record Information

Company

CooperSurgical, Inc.

Inspection Date

December 17, 2014

Product Type

Devices

Office

New England District Office

People

ID: 78b90ac6-b966-438b-8457-fccfc8b769b0

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