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CLOSEOUT LETTER

1ViZN LLC MARCS-CMS 522724 — Feb 06, 2019

1ViZN LLC - 522724 - 02/06/2019

Delivery Method:
UPS Overnight

Recipient:
Recipient Name
M. Bruce Davis
Recipient Title
Founder and President
1ViZN LLC
1ViZN LLC

1180 N Mountains Springs Parkway
Springville, UT 84663
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

6th Ave & Kipling Street
P.O.Box 25087
Denver, CO 80225
United States


The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Amended Warning Letter DEN-17-16-WL, dated August 23, 2017. Based on our evaluation, it appears that you have addressed the violation(s) 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 regulations 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/
LaTonya M. Mitchell
Program Division Director
Office of Human and Animal Food Operations -
Division IV West