FDA WARNING_LETTER - GYN Disposables, Inc. - April 12, 2011

FDA WARNING_LETTER for GYN Disposables, Inc. on April 12, 2011. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for GYN Disposables, Inc. on April 12, 2011. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.50(a)

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

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 CFR 820.100(a)(4)

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

21 CFR 820.198(c)

21 CFR 820.80(a)

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Record Information

Company

GYN Disposables, Inc.

Inspection Date

April 12, 2011

Product Type

Devices

Office

Department of Health and Human Services

People

Thomas D. Clarida

ID: acb57120-b70f-4ecd-89ad-ea0f0d44f24d

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