Inspections, Compliance, Enforcement, and Criminal Investigations
De Saegher Cattle, LLC - Close Out Letter 5/7/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
May 7, 2012
Mr. Barthel J A De Saegher, Owner
De Saegher Cattle, LLC
8068 W. Buchanan Road
Middleton, Michigan 48856
Dear Mr. De Saegher
The Food and Drug Administration has completed an evaluation of your written response regarding corrective actions to our inspection dated March 20, 21, and 28, 2012 which resulted in FDA Warning Letter 2012-DET-12, dated April 19, 2012. 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.
Michael V. Owens,
Detroit District Office