FDA WARNING_LETTER - Biosensors Interventional Technologies Pte Ltd - April 20, 2023

FDA WARNING_LETTER for Biosensors Interventional Technologies Pte Ltd on April 20, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Biosensors Interventional Technologies Pte Ltd on April 20, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

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

21 CFR 803.3

21 CFR 820.100(a)

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 803

21 CFR 820.75(a)

21 CFR 803.50(a)(2)

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Record Information

Company

Biosensors Interventional Technologies Pte Ltd

Inspection Date

April 20, 2023

Product Type

Devices

Office

Office of Health Technology 2 (Cardiovascular Devices)

People

ID: a1fc484b-417b-4217-a597-a497e0c3a701

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