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CLOSEOUT LETTER

CooperSurgical, Inc. Apr 25, 2016

CooperSurgical, Inc. - Close Out Letter 4/25/16

CooperSurgical, Inc.
  

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

 
 Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556

April 25, 2016

Mr. Paul Remmell
President & CEO
CooperSurgical, Inc.
75 Corporate Drive
Trumbull, CT 06611


Dear: Mr. Remmell:


The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 449979, dated June 9, 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/

Joseph A. Morkunas
Acting Director, Compliance Branch
New England District