Inspections, Compliance, Enforcement, and Criminal Investigations
DPT Lakewood, LLC - Close Out Letter 2/19/13
| Public Health Service Food and Drug Administration |
| Waterview Corporate Center 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 Telephone (973) 331-4900 |
Department of Health and Human ServicesFebruary 19, 2013
Mr. Eugene Ciolfi
Vice President and General Manager
DPT Lakewood, LLC
1200 Paco Way
Lakewood, New Jersey 08701-5938
Dear Mr. Ciolfi:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 12-NWJ-21, dated August 27, 2012. Based on our evaluation, it appears that you have addressed the violations 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 your firm from the responsibility of taking all 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/
CAPT Joseph F. McGinnis
Director, Compliance Branch
New Jersey District
