Monday 21 August 2017

FDA Uses FSMA Suspension Auhtority; Second Suspension Under New FSMA Powers

The US Food and Drug Administration (US FDA) suspended the food facility registration of Roos Foods of Kenton, Delaware. The facility registration is required by all food companies in order to distribute. The suspension follows the widening investigation by the FDA, Center for Disease Control (CDC) and state and local officials into a multi-state outbreak of listeriosis linked to Hispanic-style cheese products made and distributed by Roos Foods. The suspension is only the second time the Agency flexed its new power gained under the 2011 Food Safety Modernization Act. The CDC reports that a total of 8 persons infected with the outbreak strain of Listeria monocytogenes have been reported from two states -California (1), Maryland (7).

The first time the FDA suspended a facility’s registration was in November of 2012. The FDA suspended Sunland, Inc. in Portales NM following a nationwide salmonella outbreak linked to 20 states. In the case of Sunland the number of ill reached 41 before the Agency stepped in to stop all distribution and suspend operations. It was likely the deplorable conditions found during the for cause inspection at Roos Foods’ facility that prompted the current suspension.

FSMA provides the FDA authority to suspend a company’s registration when food manufactured or held there has a “reasonable probability” of causing serious health problems or death. The leaking roof and standing water likely provided the “reasonable probability” to suspend Roos Foods since both create prime breeding grounds for bacteria like Listeria.

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The FDA suspended the food facility registration of Roos Foods Inc. of Kenton Delaware on March 11, 2014 after the FDA determined there was a reasonable probability of food manufactured, processed, packed, or held by Roos Foods causing serious adverse health consequences or death to humans.

The FDA ordered the suspension after an investigation by the FDA, Centers for Disease Control and Prevention, and state and local partners linked a multi-state outbreak of listeriosis to cheeses found to be contaminated with Listeria monocytogenes and manufactured by the company. Food facility registration is required for any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States, and if the registration of a facility is suspended, no person shall introduce food from such facility into interstate or intrastate commerce in the United States. The FDA inspected the company’s facility from February 18 – March 4, 2014. During the inspection, FDA investigators found insanitary conditions including:

  • the 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.

Additionally, the FDA collected environmental samples from different areas of the facility, including the cheese processing room and various pieces of equipment.  FDA’s testing identified 12 swabs that tested positive for Listeria monocytogenes, and pulsed-field gel electrophoresis (PFGE) analysis showed that 11 of those swabs had the same  Listeria monocytogenes “DNA-fingerprint” as the outbreak strain.

In response to evidence collected during the investigation by the FDA, CDC, and state officials, the state of Delaware’s Division of Public Health issued a Cease and Desist Production and Distribution order to the firm on February 28, 2014.

The 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.

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