Pine Creek General Store

CLOSEOUT LETTER Pine Creek General Store MARCS-CMS 542508 — May 02, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Overnight Product: Food & Beverages Recipient: Recipient Name Reuben M. Yoder, Edna M. Yoder Recipient Title Owners Pine Creek General Store Ozark Country Herbs 2866 Highway 395 North Salem , AR 72576 United States Issuing Office: Center for Food Safety and Applied Nutrition United States Dear Mr. and Mrs. Yoder The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (Ref: CMS # 542508), dated March 30, 2018. 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. If you choose to reestablish or sale your operations, 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/ Jessica Hensley Director of Compliance Office of Human and Animal Food W-3 Content current as of: 05/08/2019 Regulated Product(s) Food & Beverages