CLOSEOUT LETTER
STI Pharma LLC
- Recipient:
- STI Pharma LLC
United States
- Issuing Office:
United States
| |
900 U.S. Custom House 2nd and Chestnut Street Philadelphia, PA 19106 Telephone: (215) 597-4390 |
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
June 12, 2017
Anup K. Dam (Chairman),
STI Pharma LLC
2080 Cabot Blvd W, Ste 205
Langhorne, PA 19047-1813
Dear Mr. Connollly:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 17-PHI-02, dated November 21, 2016. Based on our evaluation, it appears that you have addressed the violation(s) contained in the 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 you firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and it 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/
Yvette Johnson
Compliance Officer
Pharmaceutical Quality I Compliance Branch