Inspections, Compliance, Enforcement, and Criminal Investigations
Akers Biosciences, Inc. - Close Out Letter 9/27/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Telephone (973) 331-4900
September 27, 2012
Raymond F. Akers, Ph.D.
Akers Biosciences, Inc.
201 Grove Road
Thorofare, New Jersey 08086-2231
Dear Dr. Akers:
The Food and Drug Administration has completed an evaluation of your corrective actions ·in response to our Warning Letter (12-NWJ-01), issued on October 04, 2011. 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.
The 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.
Capt. Joseph F. MgGinnis
Director Compliance Branch
New Jersey District