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  5. Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda - Close Out Letter 6/29/18
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CLOSEOUT LETTER

Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda


Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda

 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740 

June 29, 2018

Mr. Luiz Henrique Matiazzi, President
Apis Vida lndustria e Comercio Produtos Farmaceuticos Ltda
Rua Alcidio Pagalelli, 412
Jardim Canada
Bebedouro, Brazil 14707-016

Dear Mr. Luiz Henrique Matiazzi:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #472428, issued 8/27/2015. 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/

Carrie Lawlor, Acting Chief
Dietary Supplement and Labeling Assessment
Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition