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Premier Produce LLC MARCS-CMS 553107 —

Food & Beverages
Fruit/Fruit Product

Recipient Name
Marvin T. Harned
Recipient Title
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. 

Zada L. Giles
Compliance Officer, Division V
Office of Human and Animal Foods Operations-East

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