Stoney Ridge Farm, LLC

CLOSEOUT LETTER Stoney Ridge Farm, LLC MARCS-CMS 517412 — April 02, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Stoney Ridge Farm, LLC United States Issuing Office: United States Seattle District Office 22215 261h Avenue SE, Suite 210 Bothell, Washington 98021 April 2, 2018 OVERNIGHT DELIVERY SIGNATURE REQUIRED Derek B. Gavette, Partner Stoney Ridge Farm, LLC 2092 Van Dyk Road Everson, Washington 98247 Dear Mr. Gavette: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SEA 17-10, dated April 18, 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 District Director Program Division Director Content current as of: 04/03/2018