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. Glottal Enterprises, Inc. - 03/10/2015
  1. Warning Letters


Glottal Enterprises, Inc.

Glottal Enterprises, Inc.

United States

Issuing Office:

United States


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

 New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433


March 10, 2015

Dr. Martin Rothenberg
President & CEO
Glottal Enterprises, Inc.
1201 East Fayette Street, Suite 15
Syracuse, New York 13210

Dear Dr. Rothenberg:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, NYK-2013-14, issued on April 23, 2013. Based on our evaluation of your written responses, follow-up inspection, and information provided during our regulatory meeting the Agency considers your response adequate as long as the associated medical device(s) are used in the manner purported to us. 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.



LCDR Frank Verni, RPh
Compliance Officer
FDA – New York District