FDA WARNING_LETTER - Jiangsu Caina Medical Co., Ltd - March 23, 2024

FDA WARNING_LETTER for Jiangsu Caina Medical Co., Ltd on March 23, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Jiangsu Caina Medical Co., Ltd on March 23, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.3

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.100(a)(1)

21 U.S.C. 381(a)

21 CFR 820.100(a)(2)

21 CFR 803.50(a)(2)

21 U.S.C. 351(h)

21 CFR 820.30(g)

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Record Information

Company

Jiangsu Caina Medical Co., Ltd

Inspection Date

March 23, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: dd3a2747-7533-4fb6-b2a0-5671d5a26f36

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