FDA WARNING_LETTER - Invisi Smart Technologies UK LTD - June 21, 2021

FDA WARNING_LETTER for Invisi Smart Technologies UK LTD on June 21, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Invisi Smart Technologies UK LTD on June 21, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

FD&C Act 520(g)

FD&C Act 502(o)

FD&C Act 510(k)

21 U.S.C. 351(f)(1)(B)

FD&C Act 201(h)

21 U.S.C. 321(h)

FD&C Act 515(a)

21 U.S.C. 360(k)

FD&C Act 501(f)(1)(B)

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Record Information

Company

Invisi Smart Technologies UK LTD

Inspection Date

June 21, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Binita S. Ashar (Director)

ID: ee995641-382f-450f-92fa-b9f1b741b183

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