The Sanapac Co., Inc.

CLOSEOUT LETTER The Sanapac Co., Inc. MARCS-CMS 514139 — April 06, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Mrs. Darlene Doble Recipient Title President The Sanapac Co., Inc. 524 Orange Road Dallas , PA 18612 United States Issuing Office: Human & Animal Food Division East II United States Dear Mrs. Doble: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 17-PHI-07 issued March 24, 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 wit 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/ Robin M. Rivers Compliance Officer Human and Animal Food East, Division 2 Content current as of: 04/13/2020