The complaint alleges that FDA investigators have found L. mono inside Rel's production facility on numerous occasions since 2002. Additionally, routine laboratory testing by the Department of Defense and the California Department of Public Health, Food and Drug Branch (CFDB) found L. mono in the company's processing plant and finished sandwiches. Based on recent laboratory analyses, CFDB has embargoed and seized all in-process and finished products inside the facility.
The FDA and CFDB inspections also revealed that the company repeatedly violated the current Good Manufacturing Practice (cGMP) requirements for foods. Investigators found poor employee sanitation practices and inappropriately maintained facility and manufacturing equipment, including excessive condensation dripping onto food contact surfaces.
“Rel's lack of effective measures to bring its food processing operations into compliance with the law poses a serious public health threat,” said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. “The company's failure to comply with good manufacturing practice also demonstrates the potential for the company to continue to manufacture contaminated products.”
No illnesses have been reported so far from Rel's products. Individuals who have eaten the products and who experience symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, should contact their health care professional.
Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.