Inspections, Compliance, Enforcement, and Criminal Investigations
CTI Science Inc. - Close Out Letter 3/13/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
March 13, 2012
RE: WARNING LETTER CIN-10-107927-14
Dr. Boyd Haley
CTI Science Inc.
2430 Palumbo Dr, Ste 140
Lexington, KY 40509-1117
Dear Dr. Haley:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter CIN-10-107927-14. 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.
If you have any questions about this letter, contact: Stephen J. Rabe, Compliance Officer at 513-679-2700 ext 2163.
Toniette K. Williams
Director, Compliance Branch