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CLOSEOUT LETTER

Amico Beds Corporation Apr 06, 2017

Amico Beds Corporation - Close Out Letter 4/6/17


Amico Beds Corporation

 

  

Black HHS-Blue FDA Logo

 

10903 New Hampshire Avenue
Silver Spring, MD 20993 

 
 

April 6, 2017

Paul Phagoo
Director of International Sales
Amico Beds Corporation
121 Granton Drive #21
Richmond Hill, L4B 3N4
Canada

Dear Mr. Phagoo:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #470343 dated September 1, 2015. 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/

Ronald L. Swann, MS
Acting Director
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health