U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Ital Lemon - 494240 - 01/10/2018
  1. Warning Letters

CLOSEOUT LETTER

Ital Lemon MARCS-CMS 494240 —


Recipient:
Ital Lemon

United States

Issuing Office:

United States


 

   

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740 

January 10, 2018

Mr. Virginio Bersani, General Manager
Ital Lemon S.P.A.
Via Filippo Turati, 2/4
Z.I. Mirandolina
Codogno (Lodi) 26845, Italy

Dear: Mr. Bersani:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 494240, issued May 16, 2016 Based on our evaluation, it appears you have addressed the violations contained in the 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/

Robyn R. Jones
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition 

Back to Top