U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Insight Pharmaceuticals, LLC - Close Out Letter 9/22/14
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Insight Pharmaceuticals, LLC


Insight Pharmaceuticals, LLC

  

Department of Health and Human Services' logoDepartment of Health and Human Services

PHILADELPHIA DISTRICT
 900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106

Telephone: 215-597-4390

 

September 22, 2014


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Gary R. Downing, Chief Executive Officer
Insight Pharmaceuticals, LLC
900 Northbrook Drive, Suite 200
Trevose, PA 19053


Dear Mr. Downing:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 13-PHI-31, dated September 19, 2013. 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/

Steven L. Carter
Director, Compliance Branch
Philadelphia District Office