Premier Produce LLC

CLOSEOUT LETTER Premier Produce LLC MARCS-CMS 553107 — May 31, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Fruit/Fruit Product Recipient: Recipient Name Marvin T. Harned Recipient Title Owner Premier Produce LLC 2521 Ring Road Elizabethtown , KY 42701-9107 United States Issuing Office: Center for Food Safety and Applied Nutrition United States (513) 679-2700 Dear Mr. Harned: The Food and Drug Administration (FDA) completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 553107.  Based on our evaluation, it appears 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 also serves as acknowledgement to your firm responses dated February 2, 2019, and May 27, 2019, addressing corrective actions taken to a Form FDA 483, Inspectional Observations, issued to your firm on January 31, 2019, during a follow-up inspection.  Your response indicates that you have corrected the deficiencies noted by our investigator on the Form FDA 483. We will verify the effectiveness of your corrective actions during a future inspection of your facility. 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/ Zada L. Giles Compliance Officer, Division V Office of Human and Animal Foods Operations-East Content current as of: 06/03/2019 Regulated Product(s) Food & Beverages Fruit/Fruit Product