Picket Fence Creamery LLC

CLOSEOUT LETTER Picket Fence Creamery LLC MARCS-CMS 618726 — July 15, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Product: Dietary Supplements Recipient: Recipient Name Jeffrey S. Burkhart and Jill L. Burkhart Recipient Title Co-Owners Picket Fence Creamery LLC 14583 S. Avenue Woodward , IA 50276 United States Issuing Office: Division of Human and Animal Food Operations West II United States Dear Mr. and Ms. Burkhart, The Food and Drug Administration has completed an evaluation of Picket Fence Creamery LLC corrective actions in response to our Warning Letter (CMS case #: 618726) on January 14, 2022. Based on our evaluation, it appears that you have addressed the violation(s) 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/ Matthew R. Sleeter Acting Program Division Director Office of Human and Animal Food West Division II Content current as of: 07/18/2022 Regulated Product(s) Dietary Supplements