Vilex in Tennessee, Inc

CLOSEOUT LETTER Vilex in Tennessee, Inc MARCS-CMS 543749 — March 15, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Silvia J. Southard Recipient Title President 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. Sincerely, /S/ Blake Bevill, MS Program Division Director Office of Medical Devices and Radiological Health Operations OMDRHO Division 2 - Central Content current as of: 03/20/2019