FDA WARNING_LETTER - E-Care Technology Corp. - October 25, 2019

FDA WARNING_LETTER for E-Care Technology Corp. on October 25, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for E-Care Technology Corp. on October 25, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.250(b)

21 CFR 820

21 CFR 820.72(a)

21 U.S.C. 321(h)

21 U.S.C. 381(a)

21 CFR 820.198(a)

21 U.S.C. 351(h)

21 CFR 820.30(g)

21 U.S.C. 360i

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Record Information

Company

E-Care Technology Corp.

Inspection Date

October 25, 2019

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Benjamin R. Fisher (Office Director)

ID: 1aad3d46-8f4f-4a17-84bd-54dd29871a20

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