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 I.M. Healthy brand has been implicated in an outbreak of E. coli O157:H7.
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.
FDA Form 483 (Inspectional Observations) for Dixie Dew Products, Inc.