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. Heartsine Technologies Inc - 10/02/2014
  1. Warning Letters


Heartsine Technologies Inc

Heartsine Technologies Inc

United States

Issuing Office:

United States


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

 Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106

Telephone: 215-597-4390


Via United Parcel Service

October 2, 2014

Mr. Declan O'Mahoney, CEO
HeartSine Technologies, Ltd.
203 Airport Road West
Belfast, BT3 9ED
Northern Ireland, United Kingdom

Dear Mr. O'Mahoney:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 14-PHI-04, issued on February 3, 2014. 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.




Steven L. Carter
Director, Compliance Branch
Philadelphia District Office


cc:  James C. McGuinness, Quality Manager
      HeartSine Technologies, Inc.
      121 Friends Lane
      Newtown, PA 18940 

Back to Top