FDA WARNING_LETTER - Omnisense Systems Pte Ltd. - March 04, 2021

FDA WARNING_LETTER for Omnisense Systems Pte Ltd. on March 04, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Omnisense Systems Pte Ltd. on March 04, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 331(a)

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

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

21 U.S.C. 352(o)

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Record Information

Company

Omnisense Systems Pte Ltd.

Inspection Date

March 4, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: bc99b564-b590-46f6-9d17-b32d6ac9f1f8

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