- Delivery Method:
- United States Postal Service
Recipient NameJean-Francois Durette
- Oculo-Plastik, Inc.
200 West Sauve Street
Montreal QC H3L 1Y9
- Issuing Office:
- Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Mr. Durette:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 481113, dated December 22, 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.
Ronald L. Swann, M.S.
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health
Rene Van De Zande
Emergo Group, Inc.
816 Congress Avenue, Suite 1400
Austin, Texas 78701