Intensive Nutrition Incorporated

CLOSEOUT LETTER Intensive Nutrition Incorporated MARCS-CMS 395974 — October 09, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Dietary Supplements Recipient: Recipient Name Olivia B. Melaugh Recipient Title President Intensive Nutrition Incorporated Intensive Nutrition Incorporated 1972 Republic Ave. San Leandro , CA 94577-4224 United States Issuing Office: OHAFO West Division 5 1431 Harbor Bay Parkway Alameda , CA 94502 United States October 9, 2018 RE: WL Close-Out Letter Dear Ms. Melaugh: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, dated January 22, 2014. 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 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/ Sergio Chavez Director Compliance Branch Food and Drug Administration HAF Division West 5 Content current as of: 10/11/2018 Regulated Product(s) Dietary Supplements