Unique EnCapsulation Technology LLC

CLOSEOUT LETTER Unique EnCapsulation Technology LLC MARCS-CMS 506356 — February 08, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name K.G. Rao Recipient Title Founder & CEO Unique EnCapsulation Technology LLC 9 Lenel Road Landing , NJ 07850 United States Issuing Office: Center for Food Safety and Applied Nutrition 6000 Metro Drive Suite 101 Baltimore , MD 21215 United States (410) 779-5455 Dear Mr. Rao, On November 8, 2018, the Food and Drug Administration completed an evaluation of your firm’s corrective actions in response to our Warning Letter (#506356) dated January 17, 2017. Based on our evaluation of your most recent inspection that was concluded November 8, 2018, it appears that you have 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. If you have any questions related to this letter, I can be contacted via email at rochelle.young@fda.hhs.gov or by phone at 410-779-5437. Sincerely, /S/ CDR Rochelle B. Young, RPh. MSA Office of Human & Animal Food East Division 2 Compliance Officer Content current as of: 05/15/2019 Regulated Product(s) Food & Beverages