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Vilex in Tennessee, Inc MARCS-CMS 543749 —

Recipient Name
Silvia J. Southard
Recipient Title
Vilex in Tennessee, Inc

111 Moffitt Street
McMinnville, TN 37110-2235
United States

Issuing Office:
Center for Devices and Radiological Health

555 Winderley Place
Suite 200
Maitland, FL 32751
United States

Dear Ms. Southard:

The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter #543749, dated January 8, 2018. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing requirements or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Blake Bevill, MS
Program Division Director
Office of Medical Devices and Radiological Health Operations
OMDRHO Division 2 - Central

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