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  5. Original Living Coconut, LLC - 561493 - 06/15/2020
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CLOSEOUT LETTER

Original Living Coconut, LLC MARCS-CMS 561493 —

Delivery Method:
VIA UPS
Product:
Food & Beverages
Ice Cream/Frozen Dairy

Recipient:
Recipient Name
Ms. Renee E. Ainlay
Original Living Coconut, LLC

817 W. Arnold Wallen Way
Stockton, MO 65785
United States

Issuing Office:
Office of Human and Animal Food-West Div. 2

United States

913-495-5100

Dear Ms. Ainlay:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 561493) on October 10, 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/
Andrew A. Hoopes
Compliance Officer
Office of Human and Animal Food-West Div. 2

 
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