FDA Inspection 1152056 - CardioQuip, LLC - September 17, 2021

FDA Inspection 1152056 for CardioQuip, LLC on September 17, 2021. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 1152056 for CardioQuip, LLC on September 17, 2021. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 803.17

21 CFR 820.100(b)

21 CFR 820.198(a)

21 CFR 820.198(b)

21 CFR 820.198(d)

21 CFR 820.200(a)

21 CFR 820.30(c)

21 CFR 820.30(d)

21 CFR 820.30(g)

21 CFR 820.30(i)

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Record Information

Company

CardioQuip, LLC

Inspection Date

September 17, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: fd25d0ae-a8f6-4e94-9319-165cb7d4bc78

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