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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CIBA Vision Puerto Rico, Inc. - Close Out Letter 9/14/11

  

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

Public Health Service
Food and Drug Administration
 466 Fernandez Juncos Avenue
San Juan, Puerto Rico, 00901
Compliance Branch
Telephone: 787-474-9500
FAX: 787-729-6658

September 14, 2011


CERTIFIED MAIL
Return Receipt Requested


Ms. Andrea Saia
CIBA Vision CEO
11460 Johns Creek Parkway
Duluth, GA 30097

Dear Ms. Saia:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 11-SJN-WL-02 dated December 21, 2011. 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.

Kind regards,

/s/ 

Edwin Ramos
Director of Compliance Branch
San Juan District Office