NEWS

FDA shuts down NKY company after E. coli outbreak

Sarah Brookbank
sbrookbank@enquirer.com
Jar of peanut butter.

A Northern Kentucky company had its food facility registration suspended by the Food and Drug Administration after being linked to an E.coli outbreak.

On March 28, the FDA suspended Dixie Dew Products Inc's registration because products manufactured in its 1360 Jamike Ave. facility may be contaminated. An outbreak of E. coli was reported when people became ill after eating I.M Healthy SoyNut Butter products, which are produced at the Dixie Dew facility.

The Erlanger company was inspected in March and the FDA identified unsanitary conditions that could lead to contamination with E. coli in finished products. Six samples of I.m. Healthy SoyNut Butter products were collected in California, Oregon and Washington matched the outbreak strains.

According to the FDA, on March 3, 2017, Dixie Dew refused to allow investigators access to the facility’s environmental sampling and production records and the FDA issued a demand for records.

At the close of the inspection, the FDA noted conditions seen during the inspection that needed to be corrected. Dixie Dew responded to the report, outlining a list of actions they had taken to correct the problems. The FDA found the actions were not enough and issued the Suspension Order to prevent further illnesses.

The suspension applies to the entire facility and no food product may leave the facility for sale or distribution. The FDA said it will reinstate Dixie Dew’s food facility registration only when problems are fixed.

Nine patients from this E. coli outbreak have developed hemolytic uremic syndrome, a potentially life-threatening complication, as a result of the E. coli infection. Those infected are between the ages of 1 and 57 years, with a median age of 8 years.

The FDA noted the following observations during the inspection:

  • Failure to manufacture and package foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
  • All reasonable precautions were not taken to ensure that production procedures do not contribute contamination from any source. 
  • Hand-washing facilities lacked running water of a suitable temperature. 
  • Failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing. 
  • Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated. 
  • Failure to perform microbial testing where necessary to identify possible food contamination.
  • The plant was not constructed in such a manner as to allow floors and ceilings to be adequately cleaned and kept clean and kept in good repair.
  • Failure to provide adequate ventilation to minimize odors and vapors in areas where they may contaminate food. 
  • Effective measures were not being taken to exclude pests from the processing areas.  
  • Failure to remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.