FDA Sends Warning Letter to Jensen Farms: Widespread Listeria Contamination Indicates Poor Sanitary Practices
Yesterday, the FDA sent Ryan D. Jensen and Eric S. Jensen, Co-Owners of Jensen Farms, a warning letter. Jensen Farms cantaloupe have been linked to at least 123 cases of listeriosis (illness caused by Listeria bacteria) in 26 states. The cantaloupe Listeria outbreak has proven extremely deadly--26 dead, 25 adults and one miscarriage.
The FDA warning letter outlined the results of the FDA investigation of the Jensen Farms packing facility located at 31 North Cline, Granada, Colorado and stated that the cantaloupe packed in the Jensen Farms packing facility are "adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health [were injurious to health and killed over 20 people]."
Below are excerpts from the FDA warning letter. As background, four strains of Listeria and two serotypes (1/2a and 1/2b) have been associated with the outbreak.
- During the September 10 inspection, FDA sampled cantaloupes from cases on four pallets in the cold storage in your packing facility. FDA conducted laboratory analyses, including pulsed-field gel electrophoresis (“PFGE”), on these samples. Five of the ten cantaloupes FDA analyzed were positive for Listeria monocytogenes. The PFGE analysis determined that four of the ten cantaloupes matched the strain of Listeria monocytogenes representing cluster #2, and one of the cantaloupes matched the strain of Listeria monocytogenes representing cluster # 4. Consequently, these cantaloupes from your facility are adulterated within the meaning of Section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] in that they bear or contain a poisonous or deleterious substance that may render them injurious to health.
- During the inspection, we also collected environmental swabs from various locations and surfaces throughout your packing facility. FDA conducted laboratory analyses which determined that 13 of the 39 total environmental swabs were positive for outbreak strains of Listeria monocytogenes. PFGE analysis determined that eleven of the positive swabs matched the strain of Listeria monocytogenes represented by cluster #2, one positive swab matched the strain of Listeria monocytogenes represented by cluster #4, and one positive swab matched the strain of Listeria monocytogenes represented by cluster #3. Further, one swab was positive for a strain of Listeria monocytogenes that did not match any of the outbreak strains. These positive swabs were taken from different locations throughout the washing and packing areas in your facility, all of which were either food contact surfaces or areas adjacent to food contact surfaces. This significant percentage of swabs that tested positive for outbreak strains of Listeria monocytogenes demonstrates widespread contamination throughout your facility and indicates poor sanitary practices in the facility.
- Accordingly, the cantaloupe packed in your facility are adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
