Les Produits Chimiques B.G.R., Inc.

CLOSEOUT LETTER Les Produits Chimiques B.G.R., Inc. MARCS-CMS 542247 — May 21, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: 320-18-64 Product: Drugs Recipient: Recipient Name Ms. Nathalie A. Bélanger Recipient Title Vice-President and Owner Les Produits Chimiques B.G.R., Inc. 600 Avenue Delmar Pointe-Claire QC H9R 4A8 Canada Issuing Office: Division of Drug Quality II United States Dear Ms. Bélanger: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-18-64 dated July 23, 2018. Based on our evaluation, it appears that you have adequately addressed the deviations 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 FDA 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 deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ Bill Fowler Compliance Officer Division of Drug Quality II Content current as of: 05/21/2020 Regulated Product(s) Drugs