Signa S.A. de C.V.

CLOSEOUT LETTER Signa S.A. de C.V. MARCS-CMS 605219 — July 07, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Jeff Watson Recipient Title President & Chief Executive Officer Signa S.A. de C.V. Apotex Inc. 150 Signet Drive Toronto ON M9L 1T9 Canada Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Mr. Watson: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-40 dated July 14, 2020. Based on our evaluation, it appears that you have 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/ Chhaya Shetty Compliance Officer Division of Drug Quality I Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research Content current as of: 07/15/2022 Regulated Product(s) Drugs