FDA WARNING_LETTER - Aju Pharm Co., Ltd. - January 23, 2025

FDA WARNING_LETTER for Aju Pharm Co., Ltd. on January 23, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Aju Pharm Co., Ltd. on January 23, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.250(b)

21 CFR 820.100(a)

21 CFR 803.12(a)

21 CFR 820.70(a)

21 CFR 820.198(a)

21 U.S.C. 352

21 CFR 803.18

21 CFR 820.50

21 CFR 820.30(g)

21 U.S.C. 360i

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Record Information

Company

Aju Pharm Co., Ltd.

Inspection Date

January 23, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Raquel Peat (Director)

ID: 2a86c656-cbdb-481f-a14f-a827616ed6c1

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