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  5. The Cookie Boys - Close Out Letter 5/31/18
  1. Warning Letters

CLOSEOUT LETTER

The Cookie Boys


Recipient:
The Cookie Boys


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
1431 Harbor Bay Parkway
Alameda, CA 94502-7070 

May 31, 2018
 

Mr. Jeffrey M. Heilman, Owner
The Cookie Boys
1058 Broadway Ave
San Jose, CA 95125
 

Dear Mr. Jeffrey M. Heilman:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 510024), dated March 03, 2017. 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/
Sergio Chavez
Director of Compliance
Office Human and Animal Foods
Division West 5