Inspections, Compliance, Enforcement, and Criminal Investigations
Syneron Inc. - Close Out Letter 4/3/12
| Public Health Service Food and Drug Administration |
Los Angeles District Telephone: (949) 608-2900 |
Department of Health and Human ServicesVIA 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
