FDA WARNING_LETTER - Yangzhou Yulou Paper Products Co., Ltd. - September 09, 2025

FDA WARNING_LETTER for Yangzhou Yulou Paper Products Co., Ltd. on September 09, 2025. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Yangzhou Yulou Paper Products Co., Ltd. on September 09, 2025. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 CFR 211.113(b)

FD&C Act 801(a)(3)

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

21 CFR 211.166(a)

21 CFR 211.160(b)

FD&C Act 704(a)(4)

21 CFR 211

21 CFR 210

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

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Record Information

Company

Yangzhou Yulou Paper Products Co., Ltd.

Inspection Date

September 9, 2025

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

George Tidmarsh (Director)

ID: 7209dc64-f84a-4307-aab4-9ee26c1b8d71

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