Montana Emu Ranch Company Inc

CLOSEOUT LETTER Montana Emu Ranch Company Inc MARCS-CMS 509205 — January 31, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Montana Emu Ranch Company Inc United States Issuing Office: United States Seattle District Office 22215 26th Avenue SE, Suite 210 Bothell, Washington 98021 January 31 , 2018 CERTIFIED MAIL RETURN RECEIPT REQUESTED Penelope S. Collins, Owner Montana Emu Ranch Company P.O. Box 7041 Kalispell, Montana 59904 Dear Ms. Collins: The Food and Drug Administration has completed an evaluation of your firm 's corrective actions in response to our Warning Letter SEA 17-11 dated April 20, 2017. 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/ Miriam R. Burbach Program Division Director District Director Content current as of: 09/18/2018