FDA WARNING_LETTER - Vilex in Tennessee, Inc. - August 25, 2017

FDA WARNING_LETTER for Vilex in Tennessee, Inc. on August 25, 2017. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Vilex in Tennessee, Inc. on August 25, 2017. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.90(b)(2)

21 CFR 820.50

21 U.S.C. 351(h)

21 CFR 820.30(j)

21 CFR 820.30(g)

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Record Information

Company

Vilex in Tennessee, Inc.

Inspection Date

August 25, 2017

Product Type

Devices

Office

Florida District Office

People

Kathleen M. Sinninger

ID: 478f731d-e247-46c3-89cf-6d5615bbbf9f

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