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  5. Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. - Close Out Letter 8/3/16
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CLOSEOUT LETTER

Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. 03/08/2016

Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. - Close Out Letter 8/3/16


Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda.

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993 

AUG 3, 2016
 

Mr. Haroldo Graci
General Manager
Greiner Bio One Brasil Produtos
Medicos Hospitalares Ltda.
Av. Affonso Pansan, 1967
Americana, SP, Brazil

Dear Mr. Haroldo Graci:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 423198 dated August 8, 2014. 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/

James L. Woods
Deputy Director
Patient Safety and Product Quality
Office of lnVitro Diagnostics and
Radiological Health
Center for Devices and Radiological Health