Inspections, Compliance, Enforcement, and Criminal Investigations
Premium Dental LLC - Close Out Letter 2/4/11
| Public Health Service Food and Drug Administration |
Waterview Corporate Center |
Department of Health and Human Services
Telephone (973) 331-4906
February 4,2011
Mark Neuman
President
Premium Dental, LLC
1451 Route 88, Suite 11
Brick, NJ 08724
Dear Mr. Neuman:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter Number 10-NWJ-04, dated January 14, 2010. Based on our evaluation, it appears that you have addressed the violation(s) 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.
Sincerely,
/s/
Nancy Rolli
Director, Compliance Branch
New Jersey District
