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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Isis Services, LLC - Close Out Letter 2/7/13

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

February 7, 2013


Jorge L. Garcia, DVM
Founder and Chief Scientific Officer
ISIS Services, LLC
1031 Bing Street
San Carlos, CA 94070


Dear Dr. Garcia:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective and preventive actions in response to our Warning Letter dated July 18, 2011. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this Warning Letter.

This letter does not relieve 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. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely yours,

/S/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
  Radiological Health Chief