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  5. Apira Science, Inc. - 11/19/2015
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Apira Science, Inc.

Apira Science, Inc.

United States

Issuing Office:

United States


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

 Food and Drug Administration
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506

Telephone: 949-608-2900
        FAX: 949-608-4415


November 19, 2015

Mr. Nicholas J. Brox, CEO
Apira Science, Inc.
2601 Main Street, Suite 350
Irvine, CA 92614

Dear Mr. Brox:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL # 23-12), dated 04/17/12. 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.



LCDR Steven Porter, Acting Director
Los Angeles District


Mr. Jeffrey S. Braile, President
Apira Science, Inc.
1200 North Federal Highway, Suite 130
Boca Raton, FL 33432

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