FDA WARNING_LETTER - Sunstar Americas, Inc. - February 18, 2021

FDA WARNING_LETTER for Sunstar Americas, Inc. on February 18, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sunstar Americas, Inc. on February 18, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

FD&C Act 501(a)(2)(B)

21 CFR 211.160(b)

21 CFR 211.100(b)

21 CFR 211

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 210

21 CFR 820.100(b)

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Record Information

Company

Sunstar Americas, Inc.

Inspection Date

February 18, 2021

Product Type

Devices

Office

Office of Medical Devices and Radiological Health Operations Div. 2 Central

People

ID: cd739b5d-3ba0-4da5-ad8a-a2010569cd40

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