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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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BENEV Company Inc - Close Out Letter 4/23/13

  

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

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

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

 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED


April 23, 2013


Mr. Peter Min, CEO
BENEV Company, Inc.
23263 Madero, Suite A
Mission Viejo, CA 92691-2767


Dear Mr. Min:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, WL # 20-10, dated May 18,2010 and a Regulatory Meeting held April 04, 2011. Based on our inspectional evaluation and your written responses, it appears that you have addressed the violation(s) contained in the Warning Letter.

Please be aware that as a result of our inspection dated February 22, 2013, we found that you have not resumed manufacturing of your drug products for distribution and have only manufactured validation batches of a sunscreen product. 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/

Alonza E. Cruse, Director
Los Angeles District