Bridgewater Resources, LLC

CLOSEOUT LETTER Bridgewater Resources, LLC MARCS-CMS 541081 — December 06, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Overnight Recipient: Recipient Name Robert W. Runkle, Betty R. Runkle Recipient Title Owners Bridgewater Resources, LLC Bridgewater Resources, LLC 334 Main Street Liberty , TX 77575 United States Issuing Office: Office of Human and Animal Food Operations West Division 3 4040 N. Central Expressway Suite 300 Dallas , TX 75204 United States Dear Mr., and Mrs. Robert Runkle: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (case 541081, dated March 9, 2018). 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/ Jessica E. Hensley Director, Compliance Branch Human & Animal Food Operations, WD3 Content current as of: 12/18/2018