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  5. Jubilant Generics Limited - 569799 - 04/23/2024
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CLOSEOUT LETTER

Jubilant Generics Limited MARCS-CMS 569799 —

Reference #:
3006895982
Product:
Drugs
Recipient:
Recipient Name
Dr. Jaidev Sanjeev Rajpal
Recipient Title
Managing Director & CEO
Jubilant Generics Limited

Plot No. 15, Knowledge Park – II
Greater Noida 201306
Uttar Pradesh
India

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Secondary Issuing Offices

United States

Dear Dr. Rajpal

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-15 dated March 6, 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/
Marisa Heayn
Compliance Officer
Division of Drug Quality II

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