FDA WARNING_LETTER - CardioQuip, LLC - September 17, 2021

FDA WARNING_LETTER for CardioQuip, LLC on September 17, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for CardioQuip, LLC on September 17, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 321(h)(1)

21 CFR 807.81(a)(3)

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

21 CFR 820.30(a)

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

21 CFR 820.100(a)

21 CFR 820.30(i)

21 CFR 820

21 U.S.C. 360(k)

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Record Information

Company

CardioQuip, LLC

Inspection Date

September 17, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 3f57c600-cb82-40d7-9ede-dff67473e55c

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