CLOSEOUT LETTER
Torrent Pharma Inc MARCS-CMS 584701 —
- Delivery Method:
- Return Receipt Requested
- Product:
- Drugs
- Recipient:
-
Recipient NameMr. Sanjay Gupta
-
Recipient TitlePresident and CEO
- Torrent Pharma Inc
2091 Hartel Ave.
Levittown, PA 19057
United States-
- sanjayqupta@torrentpharma.us
- Issuing Office:
- Division of Pharmaceutical Quality Operations I
United States
Dear Mr. Gupta:
The Food and Drug Administration has completed evaluation of Torrent Pharma, Inc. corrective actions in response to our Warning Letter [WL #584701, dated October 28, 2019]. Based on our evaluation, it appears that you have addressed the violation(s) 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 Agency 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/
Craig Swanson
Acting Program Division Director/District Director
Office of Pharmaceutical Quality Operations
Division I