Inspections, Compliance, Enforcement, and Criminal Investigations
Langeland Farms - Close Out Letter 1/13/14
Department of Health and Human Services
|Public Health Service|
|Food and Drug Administration|
300 River Place
Detroit, MI 48207
January 13, 2014
Merle J. Langeland, President
Marlin Langeland, Co-Owner
5085 Garfield Street
Coopersville, Michigan 49404-9486
Dear Messrs. Langeland,
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, 2013-DET-01, dated November 13, 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 actions should violations be observed during a subsequent inspection or through other means.
Tina M. Pawlowski, Ph.D.
Detroit District Office