FDA WARNING_LETTER - Tenderneeds Fertility LLC - December 13, 2019

FDA WARNING_LETTER for Tenderneeds Fertility LLC on December 13, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Tenderneeds Fertility LLC on December 13, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360(j)

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

21 CFR 820.90

21 CFR 801D

21 CFR 884.6110

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

21 CFR 820.30(a)

21 U.S.C. 360

21 U.S.C. 352(a)

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

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Record Information

Company

Tenderneeds Fertility LLC

Inspection Date

December 13, 2019

Product Type

Devices

Office

Division of Medical Device and Radiological Health Operations East

People

ID: cfc6a941-4228-4ab4-8a58-6cd506827aaf

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