Eclipse Aesthetics LLC - Close Out Letter 1/6/16
- Eclipse Aesthetics LLC
Department of Health and Human Services
|Food and Drug Administration|
Silver Spring MD 20993
January 6, 2016
Chief Executive Officer
Eclipse Aesthetics, LLC.
13988 Diplomat Drive, Suite 160
Dallas, Texas 75234
Dear Mr. O’Brien:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CBER-16-01 dated October 27, 2015. 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 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.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research