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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Biostructures, LLC - Close Out Letter 12/11/2012

  

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

December 11,2012


Mr. Russell L. Cook, CEO
Biostructures, LLC
1201 Dove Street, Suite 470
Newport Beach, CA 92660


Dear Mr. Cook:


The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, WL # 02-11, dated 10/07/10. Based on our inspectional evaluation and your written responses, it appears that you have addressed the violation(s) contained in the 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,

/S/

Alonza E. Cruse, Director
Los Angeles District