The FDA announced this evening that on March 28, 2017, the FDA used authorities granted under the 2011 FDA Food Safety Modernization Act to suspend the food facility registration of Dixie Dew Products, Inc. (Dixie Dew) of Erlanger, Kentucky, because products manufactured in this facility may be contaminated.
Soy nut butter manufactured by Dixie Dew and sold under the brand name I.M, Healthy has been implicated in an outbreak of E. coli O157:H7.
Twenty-nine people infected with the outbreak strains of STEC O157:H7 have been reported from 12 states. Arizona 4, California 5, Florida 1, Illinois 1, Massachusetts 1, Maryland 1, Missouri 1, New Jersey 1, Oregon 9, Virginia, 2, Washington 2, and Wisconsin 1.
Illnesses started on dates ranging from January 4, 2017, to March 13, 2017. Ill people range in age from 1 to 57 years, with a median age of 8. Twenty-four (83%) of the 29 ill people are younger than 18 years. Among ill people, 59% are male. Twelve ill people have been hospitalized, and nine people developed hemolytic uremic syndrome.
The FDA’s decision to suspend the registration of Dixie Dew Products was prompted by the E. coli O157:H7 outbreak and the findings of FDA’s March 2017 inspection of Dixie Dew, which identified insanitary conditions that could lead to contamination with E. coli O157:H7 in finished products.
No food can leave the Dixie Dew facility for sale or distribution while the food facility registration is suspended.
On March 28, 2017, the FDA issued a Suspension of Food Facility Registration Order to Dixie Dew of Erlanger, Kentucky, after an inspection revealed insanitary conditions at the firm that could affect the safety of finished products.
The FDA inspected the facility between March 3 and 15, 2017. On March 3, 2017, Dixie Dew refused to allow FDA investigators access to the facility’s environmental sampling and production records; the FDA subsequently issued a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act. After receiving the Demand for Records, Dixie Dew provided FDA investigators with the necessary records. At the close of the inspection, the FDA provided Dixie Dew with a list of the investigators’ inspectional observations (Form FDA 483), noting objectionable conditions seen during the inspection. Dixie Dew responded to the report in writing with a list of actions the firm has taken to correct the conditions; however, FDA found the corrective actions were not adequate to fully address the risks that were identified, and issued the Suspension Order to prevent further illnesses from occurring.
The Suspension Order applies to the entire facility. While the order is in effect, no food product may leave the facility for sale or distribution.
Specific problems noted in the suspension order and Form 483 included (blanks reflect redacted information):
- investigators observed grossly insanitary conditions that cause your firm’s soy nut butter products to be adulterated;
- food contact surfaces, floors, walls, and ceilings in the soy nut butter processing and packaging rooms were heavily coated with soy nut butter build-up from previous production runs.
- firm does not routinely wash and sanitize smaller pipes, pipe fittings, gaskets, seals, “or the rubber _____ plug” when broken down following a production run;
- firm does not conduct a kill step for SoyNut Butter product remaining in your firm’s mixing kettle leftover from a production run;
- plant Manager stated, up to _____ may remain in the kettle overnight or weekend prior to resuming production. You and your Plant Manager stated the kettle is shut off when product remains in the kettle overnight and/or over the weekend;
- plant manager and maintenance supervisor reported your _____ machine, used for fine mixing of the SoyNut Butter and ________, routinely shuts off during processing. Your Plant Manager stated this occurs one to two times per day and, this problem has persisted for approximately 15 years despite repeated maintenance intended to correct the problem;
- firm monitors the SoyNut ______ with a ______ thermometer, but plant manager stated he has never verified the accuracy of this instrument;
- you and your plant manager report,your temperature probe and chart recorder, initially engineered to verify and record _____ of product in the large mixing kettle, is not functioning properly and has not been used for well over a year.
FDA inspectors also noted problems with Dixie Dew’s food safety testing program, noting the company’s “failure to perform microbial testing where necessary to identify possible food contamination.” Inspectors found the testing materials on hand at Dixie Dew had expired in July 2016 and October 2015.
Problems in the Dixie Dew quality control lab were described in detail by FDA inspectors.
“An apparent fly infestation in your firm’s Quality Control and Product Development Laboratory was observed on 3/13/2017. Small apparent flies and fly larvae, too numerous to count, were inside an unplugged chest freezer,” according to the 483 report.
“A sealed blue plastic bag was inside the freezer and according to your plant manager, contained an egg product that became rotten when power was disconnected. The small apparent flies were observed along the laboratory counters and flying throughout the laboratory.”
FDA Form 483 (Inspectional Observations) for Dixie Dew Products, Inc.