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  1. Warning Letters


Signa S.A. de C.V. MARCS-CMS 605219 —

Delivery Method:
VIA Electronic Mail

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

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.

Chhaya Shetty
Compliance Officer
Division of Drug Quality I
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

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