Apollo Health And Beauty Care, Inc.

CLOSEOUT LETTER Apollo Health And Beauty Care, Inc. MARCS-CMS 593033 — July 22, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: 320-20-15 Product: Drugs Recipient: Recipient Name Mr. Charles Wachsberg Recipient Title Chief Executive Officer Apollo Health And Beauty Care, Inc. 1 Apollo Place North York ON M3J 0H2 Canada Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Mr. Wachsberg: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-15 dated December 23, 2019. 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 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 violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Michael Klapal Compliance Officer Division of Drug Quality II Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research Content current as of: 07/25/2022 Regulated Product(s) Drugs