Blue Bell Creameries knew it had a listeria problem as early as 2013, and it has failed to make its ice creams and sorbets in a way that would minimize the possibility of contamination, according to
The report on the Blue Bell plant in Broken Arrow, Okla., found the most egregious problems.
On five occasions in 2013 and 10 in 2014, listeria was found in the plant's processing room and kitchen on surfaces that did not come in contact with food, the FDA said. And the report found that on at least one occasion, after the plant performed its usual cleaning and sanitizing procedures, listeria was found again in the same place, and the coliform bacteria count was higher than before the cleaning.
The plant also failed to test for bacteria on food contact surfaces, the report said.
The FDA found lapses in hand-washing and glove-changing as well. For example, the report said, one worker was observed picking up buckets of orange puree from "wet wood pallets which had black mold-like residue and red stains" and then, without changing gloves, touching the rims and insides of the buckets.
Water used to clean equipment, utensils and food-packaging materials was not sufficiently hot, the report found, and ingredients, including unpasteurized milk products, were stored at temperatures that were not sufficiently cold.
Furthermore, the report said, condensation that gathered on equipment dripped into tanks containing ingredients and even into quart containers of finished product.
The plant also used some equipment that was difficult or impossible to clean properly, such as porous wood pallets and a stainless-steel mixer with rough welding, the report said.
Blue Bell did not respond Thursday afternoon to phone calls and emails requesting comment.
The FDA wasn't aware that Blue Bell had found listeria in 2013 until the agency performed its 2015 inspection, FDA spokeswoman Lauren E. Sucher said Thursday.
However, not all listeria strains cause disease, Sucher said, and when listeria is found in manufacturing facilities but not in food "it is not uncommon for a company to immediately take corrective action, rather than test further to see if the strain of listeria poses a threat."
Blue Bell did not determine if the listeria was a threat, so it's not known if it was Listeria monocytogenes or a nonthreatening strain, according to Sucher, who added that the FDA was working with Blue Bell to ensure that the company was complying with food safety regulations.
The Listeria monocytogenes bacteria can cause serious and sometimes fatal infections, especially in young children, the elderly and those with weakened immune systems, and it has been known to cause miscarriages and stillbirths. Healthy adults may experience symptoms such as high fever, severe headache, stiff neck, nausea, abdominal pain and diarrhea.
According to the Centers for Disease Control and Prevention, 10 people — five in Kansas, three in Texas and one each in Arizona and Oklahoma — are confirmed to have had listeriosis linked to Blue Bell products. All 10 patients were hospitalized, and three in Kansas died, officials said. The illnesses date as far back as January 2010.
Blue Bell recalled all of its products worldwide last month because of listeria concerns.
The company has said it is expanding its testing and safety procedures. The measures include "expanding our system of swabbing and testing our plant environment by 800% to include more surfaces" and "sending samples daily to a leading microbiology laboratory for testing," it says on its website.
The situation at Blue Bell "is pretty bad," said Doug Powell, a former Kansas State University professor of food safety who now publishes the food safety website Barfblog. Given the FDA's findings, he said, "it's not surprising there was an outbreak."
Blue Bell should have told customers when listeria was first found at the Broken Arrow plant in 2013, and it should have moved to fix the problem right away, Powell said.
By contrast, Powell said, Jeni's Splendid Ice Creams, which is also dealing with a listeria problem, has done a much better job: "They have not been linked to any sick people, but as soon as they found listeria, they just shut down everything."