The U.S. Food and Drug Administration (FDA) has released the form 483 inspection report for Urbana, IL-based Tiny Greens Organic Farms.
It sheds more light on how Tiny Greens sprouts may have become contaminated with Salmonella, causing at least 125 people in 22 states to become infected.
Tiny Greens recalled specific lots of its sprouts last Dec. 29 after FDA found the product was the likely source of a Salmonella outbreak associated with Jimmy John’s Gourmet Sandwiches, a national fast-food chain.
The form 483 provides details of what FDA inspectors found at Tiny Greens during the course of their investigation. A principal finding was that sprouts were found growing in “soil from the organic material decomposed outside” without any “kill step” to prevent the sort of contamination that led to the outbreak.
Other findings included:
- An “amphibian/reptile” was kept in the reception room of the firm, which adjoined the production area.
- The farm couldn’t show that its antimicrobial treatment for seeds, which was not specifically described in the report, was equivalent to the recommended treatment with a bleach solution.
- Employees stored their lunches, including such items as raw bacon, in the cooler where finished sprouts were stored.
- Organic matter was seen on a table where sprouts were packaged, and a “biofilm-like buildup” was seen on sprouting trays after they were cleaned.
- There was apparent mold on the walls and ceiling of the mung-bean sprouting room.
- Condensation dripped from the ceiling in production areas throughout the inspection period, which lasted close to a month.
- An outside lab that the firm used to test its water and sprouts used a method that was not validated for detecting Salmonella in those items.
FDA had earlier found water run-off contaminated with the outbreak strain of Salmonella. At that time, Tiny Greens owner Bill Bagby said neither FDA nor the Illinois Department of Public health was using comprehensive tests.
The last report from the federal Centers for Disease Control and Prevention in Atlanta—issued in mid January–tallied 125 individuals in 22 states sharing the outbreak strain of infection, Salmonella serotype I 4,[5],12:i.
CDC said FDA’s water run-off samples were “indistinguishable from the outbreak strain,” but the product samples had been negative.
In the last 15 years, sprouts have been responsible for at least 30 outbreaks, usually for Salmonella and E. coli. This outbreak prompted Champaign, IL-based Jimmy John’s to drop alfalfa sprouts in favor of clover sprouts for all its franchised units.