CLOSEOUT LETTER

Innovita, LLC MARCS-CMS 521883 — July 23, 2018

Product:: Food & Beverages

Recipient:: Recipient Name

Anil K. Bhaskar; Recipient Title

CEO/Owner; Innovita, LLC; Biovation Labs, LLC; 2323 S 3600 W
West Valley, UT 84119
United States

Issuing Office:: Center for Food Safety and Applied Nutrition; United States

Dear Mr. Bhaskar:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter DEN-11-06-WL, issued on December 28, 2010 to your company Novacare, LLC (TSN Labs), now Biovation Labs, LLC. 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
Denver District Director
Program Division Director
Office of Human and Animal Foods
Division IV West (HAF4W)

Cc: Justin L. Bath, President
       Biovation Labs, LLC
       2323 S 3600 W
       Salt Lake City, UT 84119