FDA WARNING_LETTER - Aqualex Co., Ltd. - October 20, 2023

FDA WARNING_LETTER for Aqualex Co., Ltd. on October 20, 2023. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Aqualex Co., Ltd. on October 20, 2023. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 U.S.C. 331(d)

FD&C Act 801(a)(3)

21 U.S.C. 355h

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

21 CFR 211.166(a)

21 U.S.C. 331(a)

21.U.S.C. 355(a)

21 U.S.C. 352(a)

21 CFR 211

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Record Information

Company

Aqualex Co., Ltd.

Inspection Date

October 20, 2023

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: d8ba605a-2f7b-49d4-9fa4-ffcf972fc776

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