Inspections, Compliance, Enforcement, and Criminal Investigations
The Lebanon Corp, Inc. - Close Out Letter 9/13/13
Department of Health and Human Services
|Food and Drug Administration|
Detroit District Office
300 River Place, Suite 5900
Detroit, MI 48207
Telephone: (313) 393-8100
Fax: (313) 393-8139
September 13, 2013
Mr. David A. Honan, President
The Lebanon Corp, Inc.
Lebanon, IN 46052-7273
Dear Mr. Honan:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to the Warning Letter we issued to you on May 17, 2012. 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.
Additionally, we have reviewed your response to your most recent FDA inspection, dated July 12, 2013 and August 13,2013. We are unable to determine the adequacy of your response as you did not submit evidence of implementation of the corrections you describe in your correspondence. If you would like for us to evaluate the adequacy of your corrective actions, please submit objective evidence of implementation of the corrections mentioned in your correspondence. In any case, the adequacy of all of your firm's corrective actions will be evaluated during your next FDA inspection.
CDR Kimberly Martin
Compliance Officer, Detroit District