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CLOSEOUT LETTER

Cooper Vision Caribbean Corp.


Cooper Vision Caribbean Corp.

  

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

Food and Drug Administration
 San Juan District
466 Fernandez Juncos Avenue
San Juan PR 00901-3223
Telephone: (787) 729-8500
           FAX: (787) 729-6658

15-SJN-WLCOL-01


October 20, 2014


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. Robert Weiss
President and CEO
Cooper Companies Inc.
6140 Stoneridge Mall Road
Pleasanton, California 94588


Dear Mr. Weiss:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 14-SJN-WL-01, dated February 27, 2014. 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 yours,

/S/

Edwin Ramos
Director of Compliance
San Juan District Office
 

 

cc:
Mr. Rolando Torres, VP
Molding Manufacturing Americas
500 Road 584
Amuelas Industrial Park
Juana Diaz, PR 00795