B & H Foods in North Carolina is on notice from the FDA because the same strain of Listeria monocytogenes has been confirmed repeatedly during the past five years at its facilities.
“Based on FDA’s analytical results for the environmental sample and inspectional findings documented during the inspection, we have determined that your RTE (ready-to-eat) food products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act),” according to a warning letter the Food and Drug Administration sent to the company on Nov. 14.
The violations render the firm’s food products adulterated in that they have been prepared, packed, or held under conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath. The FDA previously sent the company a warning letter in October 2012, citing many of the same problems.
In February this year the company recalled Ruth’s brand pimento and cream cheese spreads because of potential contamination with Listeria monocytogenes.
Listeria monocytogenes causes serious, sometimes fatal, infections when people ingest it. Young children, the elderly and people with compromised immune systems are particularly at risk.
Staff from the FDA inspected the Charlotte, NC, location of B & H Foods on May 9 through 31. Environmental samples collected from facility returned positive results during laboratory testing for Listeria monocytogenes.
“The presence of L. monocytogenes in your facility is significant in that they demonstrate your cleaning and sanitation practices are inadequate to effectively control pathogens in your facility to prevent contamination of food,” according to the letter sent to Stanley C. Bracey, president, and Bill R. Rudisill, general manager.
“Once established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product.”
Although the firm responded to the FDA in June and July with several letters including a narrative description of the corrective actions taken, the FDA noted unresolved, significant violations.
A second strain of Listeria found in the firm’s facility was identical to WGS database isolates from FDA’s February 2017 sample of the Chester, SC, facility’s pimento spread, the state of North Carolina’s 2017 sample of your pimento cheese and old fashioned spread, and FDA environmental swabs collected from your Chester, SC, facility in May 2012, August 2013 and April 2015.
“This evidence demonstrates that L. monocytogenes has maintained a presence in your Chester, SC, facility from 2012-2015 and an identical strain of L. monocytogenes has been isolated in your Charlotte, NC, processing environment,” the warning letter stated.
The FDA noted that it cannot assess the adequacy of the firm’s corrective actions because the firm did not provide documentation of the steps taken to eliminate Listeria from the processing environment or to effectively prevent it from contaminating finished products manufactured there in the future.
According to the warning letter, the firm also failed to manufacture, package, and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Problems the FDA cited in its warning letter included failure to ensure controls necessary to minimize the potential for growth of microorganisms and contamination. “Investigators observed the soiled garments of employees, including hair nets, arm guards, and aprons, coming into direct contact with raw ingredients and in-process finished product.”
Inspectors also noted that the firm failed to ensure all equipment, containers and utensils are constructed, handled and maintained during manufacturing or storage in a manner protecting against contamination.
“Further, two pallets of canned pimentos and one pallet of canned jalapenos were observed to be stored in the maintenance shop. The pallet of jalapenos had opened motor oil containers and lubricants stored on top. The front pallet of pimento had a viscous black liquid spilled onto the middle cans on the pallet. Chemical drums stored adjacent to the rear kitchen were observed to be leaking onto open boxes of finished product containers.”
The firm’s facility is not constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and in good repair and that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, according to the warning letter.
“During the inspection condensate was observed dripping onto packaged product, exposed raw materials such as relish and cabbage, and food contact surfaces. Condensate was also observed pooling where sanitized production equipment was being stored.”
The firm also lacked proper glove, hand washing, sanitizing, and drying operations, therefore failing to ensure that all personnel working in direct contact with food, food contact surfaces, and food packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food.
Additionally, the firm’s plumbing constitutes a source of contamination to food, equipment, and utensils as “the equipment washing sink in the front kitchen was observed to be directly plumbed into the sewer system without an air break or a backflow prevention device.”
Food companies are given 15 working days to respond to FDA warning letters. Failure to take prompt action to correct the violations in warning letters can result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction, according to the warning letter.
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