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  5. Zydus Lifesciences Limited - 584856 - 11/03/2022
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CLOSEOUT LETTER

Zydus Lifesciences Limited MARCS-CMS 584856 —

Reference #:
3002984011
Product:
Drugs
Recipient:
Recipient Name
Dr. Shavril Patel
Recipient Title
Managing Director
Zydus Lifesciences Limited
Cadila Healthcare Limited

Khoraj (Gandhinagar)
Nr. Vaishmodevi Circle
Ahmedabad 382481
Gujarat
India

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Dear Dr. Patel:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-05 dated October 29, 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/
for
Rebecca Parrilla
Compliance Officer
Division of Drug Quality I

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