Queten Research Institute

CLOSEOUT LETTER Queten Research Institute MARCS-CMS 610021 — June 28, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Recipient: Recipient Name Jill Seropian Recipient Title VP Queten Research Institute 10 Bloomfield Ave. Pine Brook , NJ 07058 United States Issuing Office: Division of Human and Animal Food Operations East II United States Dear Ms. Seropian: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter issued to Queten Research Institute on November 5, 2020. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in the 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/ Andrew Ciaccia Compliance Officer Human and Animal Food East, Division II Content current as of: 07/02/2021 Regulated Product(s) Food & Beverages