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  5. Torrent Pharmaceuticals Limited - 585255 - 09/04/2024
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CLOSEOUT LETTER

Torrent Pharmaceuticals Limited MARCS-CMS 585255 —

Reference #:
FEI 3005029956
Product:
Drugs
Recipient:
Recipient Name
Mr. Jinesh Shah
Recipient Title
Director and Board of Director
Torrent Pharmaceuticals Limited

Taluka-Kadi, Ahmedabad Mehsana Highway
Indrad 382721
Gujarat
India

Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

Secondary Issuing Offices

United States

Dear Mr. Shah:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-03 dated October 8, 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 or deviations be observed during a subsequent inspection or through other means.


Sincerely,
/S/
Bryce Hammer
Compliance Officer
Division of Drug Quality II

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