U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Jeni's Splendid Ice Creams, LLC - Close Out Letter 6/2/17
  1. Warning Letters

CLOSEOUT LETTER

Jeni's Splendid Ice Creams, LLC


Jeni's Splendid Ice Creams, LLC

 

  

Black HHS-Blue FDA Logo

 

 

 
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772 

June 2, 2017

John Lowe, IV
President and CEO
Jeni’s Splendid Ice Creams, LLC
401 N. Front Street, Suite 300
Columbus, OH 43215

Dear Mr. Lowe:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter CIN-16-492668-20. Based on our evaluation, it appears that you have addressed the violation(s) 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/

Stephen J. Rabe
Compliance Officer