WASHINGTON—The U.S. Food and Drug Administration (FDA) on March 11 suspended the food facility registration of Delaware-based Roos Foods, Inc., after the agency determined there was a reasonable probability that food manufactured, processed, packed or held by the company could cause serious adverse health consequences or death to humans.

FDA ordered the suspension after a multi-agency investigation linked a multi-state outbreak of listeriosis to Hispanic-style cheeses found to be contaminated with Listeria monocytogenes and manufactured by the company. According the Centers for Disease Control and Prevention (CDC) illness onset ranged from Aug. 1 to Nov. 27, 2013. The outbreak has cause one death in California and seven hospitalizations in California and Maryland.

On Feb. 23, Roos Foods issued a recall of specific lots of Hispanic-style cheeses sold at retailers; the recall was expanded on March 1 to include all product sizes and containers of Santa Rosa de Lima Queso Duro Blando (hard cheese), and Mexicana Queso Cojito Molido.

FDA inspected the company’s facility from Feb. 18 to March 4, 2014. During the inspection, FDA investigators found insanitary conditions including a roof leaking so badly that water was raining down into the cheese processing room, including onto the cheese processing equipment and storage tanks; standing water on the floor throughout the cheese curd processing room in proximity to the cheese vats and in the storage rooms; metal roof/ceiling and metal supports exhibiting a rusted appearance with metal flaking precluding effective cleaning and sanitizing; food residues found on equipment after cleaning had been performed; openings to milk storage tanks and transfer piping were not capped to prevent contaminants from entering or contaminating food contact surfaces; and floors, wall, and equipment that were deteriorated and in bad repair, including processing equipment and storage vats with rust holes and floors with rough concrete deterioration.

The agency also collected environmental samples from different areas of the facility, including the cheese processing room and various pieces of equipment. Testing identified 12 swabs that tested positive for L. monocytogenes, and pulsed-field gel electrophoresis (PFGE) analysis showed 11 of those swabs had the same L. monocytogenes “DNA-fingerprint" as the outbreak strain.

FDA will vacate the suspension order and reinstate Roos Foods’ facility registration when the FDA determines that food manufactured, processed, packed, or held at the facility no longer has a reasonable probability of causing serious adverse health consequences or death to humans.