FDA WARNING_LETTER - Indus Medicare Limited - January 23, 2020

FDA WARNING_LETTER for Indus Medicare Limited on January 23, 2020. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Indus Medicare Limited on January 23, 2020. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 352(t)(2)

21 CFR 820.30(a)

21 CFR 820.80(c)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.90(b)(2)

21 U.S.C. 381(a)

21 CFR 803

21 CFR 820.75(a)

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Record Information

Company

Indus Medicare Limited

Inspection Date

January 23, 2020

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 08e32295-ee86-4c4a-9ba8-0048767ae7a4

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