FDA WARNING_LETTER - Sunstar Guangzhou Ltd. - June 28, 2019

FDA WARNING_LETTER for Sunstar Guangzhou Ltd. on June 28, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sunstar Guangzhou Ltd. on June 28, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 801(a)(3)

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

21 CFR 211.160(b)

21 CFR 211

21 CFR 211.165(a)

21 CFR 210

21 CFR 211.22(a)

21 U.S.C. 381(a)(3)

21 U.S.C. 351(a)(2)(B)

21 CFR 211.84(d)(1)

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Record Information

Company

Sunstar Guangzhou Ltd.

Inspection Date

June 28, 2019

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Francis Godwin (Director)

ID: 896ca40d-605b-42fc-85d7-0d4de67cf1cd

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