Inspections, Compliance, Enforcement, and Criminal Investigations
Lumen Soy Foods, LLC - Close Out Letter 5/24/12
| Public Health Service Food and Drug Administration |
New Orleans District |
Department of Health and Human ServicesMay 24, 2012
Dana Dykstra, President
Lumen Soy Foods, LLC
16142 Harbor View Drive
Spring Lake, Michigan 49456
Dear Mr. Dykstra:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter No. 2011-NOL-16, dated May 25, 2011. Based on our evaluation, it appears 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.
Sincerely,
/s/
Ruth P. Dixon
Compliance Branch Director
New Orleans District
cc: David T. Masciarelli, COO
Lumen Soy Foods, LLC
838 East Highway # 103
Lexington, Kentucky 40502
Kevin Marcantel, Operation Manager
Lumen Soy Foods, LLC
409 Scott Street
Lake Charles, Louisiana 70601
