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NVN Therapeutics

NVN Therapeutics

United States

Issuing Office:

United States


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

Public Health Service
Food and Drug Administration
 College Park, MD 20740

February 28, 2014

Brian Martin
Director Regulatory Affairs and Quality Control
Oculus, Inc.
1129 N. McDowell Blvd.
Petaluma, CA 94954

Dear Mr. Martin:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter issued December 26, 2013. 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 fum 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.

Latasha A. Robinson
Acting Team Leader
Office of Compliance
Center for Food Safety
     and Applied Nutrition

cc: FDA Los Angeles District

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