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CLOSEOUT LETTER

STI Pharma LLC


STI Pharma LLC

 

  

Black HHS-Blue FDA Logo

 

 

 
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