FDA WARNING_LETTER - A. Nelson & Co., Ltd. - September 19, 2025

FDA WARNING_LETTER for A. Nelson & Co., Ltd. on September 19, 2025. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for A. Nelson & Co., Ltd. on September 19, 2025. 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

21 CFR 210

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

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

21 CFR 211.34

21 CFR 211.165(b)

21 CFR 211.22(d)

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Record Information

Company

A. Nelson & Co., Ltd.

Inspection Date

September 19, 2025

Product Type

drugs

Office

Center for Drug Evaluation and Research

People

ID: 66a354b2-f3c1-483b-8513-0b5d19d3edce

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