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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Syneron Inc. - Close Out Letter 4/3/12

  

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

Public Health Service
Food and Drug Administration
 

Los Angeles District
19701 Fairchild
Irvine, California 92612-2506

Telephone: (949) 608-2900
         Fax: (949) 608-4415 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUESTED

April 3, 2012

Mr. Louis P. Scafuri, CEO
Syneron Inc.
3 Goodyear, Suite A
Irvine, California 92618

Dear Mr. Scafuri:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL # 17-11 dated December 23, 2010. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these collections.

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
District Director
Los Angeles District


CC:

  Mr. Christopher Carlton, President'
  Syneron Inc .
  3 Goodyear
  Irvine, CA 92618
 

  Mr. Louis P. Scafuri, CEO
  Syneron Medical LTD
  Sultam Industrial Park
  Yokneam, Illit
  20692 Israel