Inspections, Compliance, Enforcement, and Criminal Investigations
Bobby Chez, Inc., - Close Out Letter 2/24/12
| Public Health Service Food and Drug Administration |
10 Waterview Blvd., 3rd Floor |
Department of Health and Human ServicesFebruary 24, 2012
Mr. Robert E. Sliwowski
President
Bobby Chez, Inc.
Village Walk
1990 Route 70 East
Cherry Hill, NJ 08034
Dear Mr. Sliwowski:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 11-NWJ-04, dated November 17, 2010. 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.
Sincerely,
/s/
CAPT Joseph F. McGinnis
Director, Compliance Branch
New Jersey District
