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  5. Pentax of America, Inc. - Close Out Letter 1/26/18
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CLOSEOUT LETTER

Pentax of America, Inc.


Recipient:
Pentax of America, Inc.


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

Office of Medical Device and Radiological Health Operations (Division 1)
One Montvale Avenue
Stoneham, MA 02180 

 
 

January 26, 2018

David Woods
President
PENTAX of America, Inc.
3 Paragon Drive
Montvale, New Jersey 07645-1725

Dear Mr. Woods,

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to the Warning Letter [13-NWJ-06, dated March 29, 2013], issued to KayPENTAX, A Division of PENTAX Medical Company. 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/

Gina Brackett
Acting Director, Compliance Branch
Office of Medical Device and Radiological Health Operations, Division 1