FDA WARNING_LETTER - TFS Manufacturing Pty Ltd. - August 20, 2015

FDA WARNING_LETTER for TFS Manufacturing Pty Ltd. on August 20, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for TFS Manufacturing Pty Ltd. on August 20, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 820.100(a)

21 CFR 820.50(a)(2)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 381(a)

21 CFR 820.198(a)

21 CFR 820.30(f)

21 U.S.C. 351(h)

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Record Information

Company

TFS Manufacturing Pty Ltd.

Inspection Date

August 20, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Sean M. Boyd (Office Director)

ID: 57c6b703-4f55-4585-aba6-b74cad5707f5

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