EMcision Ltd. - Close Out Letter 9/14/15
- EMcision Ltd.
Department of Health and Human Services
|Food and Drug Administration|
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993
SEP 14 2015
Chief Executive Officer, EMcision Ltd.
c/o EMcision International Inc.
300 Place d'Youville
Montreal, QC H2Y 2B6
Dear Mr. Habib:
The United States Food and Drug Administration (FDA) completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS # 440200, dated November 20, 2014. 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.
If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch at +1 (240) 402-4020 (phone) or +1 (301) 847-8139 (fax).
Carl Fischer, Ph.D.
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health