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CLOSEOUT LETTER

Ropack, Inc. Apr 23, 2018

Ropack, Inc. - Close Out Letter 4/23/18


Recipient:
Ropack, Inc.


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

April 23, 2018

Yves Massicotte
President and Chief Executive Officer
Ropack, Inc.
10801 Mirabeau Street
Montreal H1J 1T7
Canada

Dear Mr. Massicotte:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, CMS # 499580, dated August 3, 2016. Based on our evaluation, it appears that you have addressed the violations 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/

CAPT Raquel Peat, PhD, MPH, USPHS
Director
Division of Premarket and Labeling Compliance
Office of Compliance
Center for Devices and Radiological Health