- Reference #:
Recipient NamePaul D. Hafey
Recipient TitlePresident and CEO
- Sovereign Pharmaceuticals, LLC
7590 Sand Street
Fort Worth, TX 76118
- Issuing Office:
- Center for Drug Evaluation and Research
4040 N. Central Expressway
Dallas, TX 75204
The Food and Drug Administration has completed evaluation of corrective actions in response to our Warning Letter 2013-DAL-WL-28, dated January 29, 2013. 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 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.
John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,