CLOSEOUT LETTER
Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC MARCS-CMS 654751 —
- Delivery Method:
- Via Email
- Reference #:
- 2851, CMS 654751
- Product:
- Drugs
- Recipient:
-
Recipient NameKunjal Joshi
- Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC
2004 Orville Drive North
Ronkonkoma, NY 11779
United States-
- kunjal@prodosepharma.com
- kunjal@spiritpharma.com
- Issuing Office:
- Center for Drug Evaluation and Research (CDER)
United States
United States
Dear Kunjal Joshi:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2851, CMS 654751. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA 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/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration