Inspections, Compliance, Enforcement, and Criminal Investigations
Cogent Solutions Group, L.L.C. 3/30/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
March 30, 2011
James D. Smith, Jr.
CEO and General Manager
Cogent Solutions Group, L.L.C.
P.O. Box 11686
Lexington, Kentucky 40577
RE: WARNING LETTER CIN-10-89724-10
Dear Mr. Smith:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to Warning Letter CIN-10-89724-10, dated May 12, 2010. Based on our evaluation, it appears that you have addressed the violations stated 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 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.
Karen Gale Sego