FDA WARNING_LETTER - Carroll-Baccari, Inc. - October 16, 2019

FDA WARNING_LETTER for Carroll-Baccari, Inc. on October 16, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Carroll-Baccari, Inc. on October 16, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

21 CFR 820.120

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

FD&C Act 501(h)

21 CFR 803.17(a)(3)

21 CFR 820.80(c)

21 CFR 820.100(a)

21 CFR 803.50(a)

FD&C Act 201(h)

21 U.S.C. 321(h)

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Record Information

Company

Carroll-Baccari, Inc.

Inspection Date

October 16, 2019

Product Type

Devices

Office

Division of Medical Device and Radiological Health Operations Central

People

Blake Bevill (Director)

ID: d6c6bdab-ecfe-433a-80a4-a4e361ecc901

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