Formulife, Inc.

CLOSEOUT LETTER Formulife, Inc. MARCS-CMS 508605 — March 02, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Formulife, Inc. United States Issuing Office: United States Office of Human &Animal Food Operations, West Division 3 4040 North Central Expressway, Suite 300 Dallas, Texas 75204 March 2, 2018 UPS Overnight Brandon M. Smith, Owner and President Formulife, Inc. Purus Labs, Inc. 1253 Andrews Parkway Allen, Texas 75002-2692 Dear Mr. Smith: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letters (2012-DAL-WL-12, January 18, 2012; 2013-DAL-WL-38, June 17, 2013; and 2017-DAL-WL-21, May 12, 2017). Based on our evaluation, it appears that you have addressed the violations contained in these Warning Letters. 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/ Chad J. Whitwell Acting Director, Compliance Branch Human & Animal Food Operations, WD3 Content current as of: 03/05/2018