All of the FDA inspection reports can be found here. Included in this is the response to the FDA 483 report. Blue Bell informed FDA of their plans to introduce tough measures to control Listeria.
While the organism was found in two of the facilities, it was not found in the Texas facility even though product from that facility was linked to illness. This can be the case with Listeria in that it only surfaces once in a while. Because of this, vigilant control measures are needed.
So you can think of what they had in terms of setting some mouse traps in your house. The set some mouse traps around and in a few traps they caught a mouse. They cleaned up a bit and reset the trap and caught another mouse. Cleaned again, reset the trap. No mouse. Done? Not really. The problem is that when you catch a mouse, you have to understand the potential for mice in other spots, especially around your food (zone 1). Determination have to be made on where the mouse came from and whether that mouse got into your food. With this, you have to put measures in place to prevent the mouse from getting anywhere in your house.
Blue Bell can't identify listeria source at Brenham plant
By Mark Collette
June 10, 2015 Updated: June 10, 2015 11:04pm
Blue Bell may never learn how listeria got into the ice cream at its Brenham plant, according to documents released Wednesday by the U.S. Food and Drug Administration, but the company plans to introduce some of the toughest bacterial control measures in the industry.
Brenham is the largest of Blue Bell's three plants and its sheer size may have hampered the hunt for contamination points. FDA inspectors swabbed 186 surfaces in the plant in March and didn't find any listeria species. That's despite ice cream from the plant being definitively linked to illnesses.
The company had better luck in Oklahoma, where preliminary evaluations of its Broken Arrow facility indicated that equipment and ingredient buckets in a storage room could have been contaminated by listeria particles escaping from a floor drain and that a machine that fills ice cream containers might have harbored the bacteria. Inspectors swabbed 221 surfaces in Broken Arrow and found the illness-causing species, listeria monocytogenes, on 15 of them.
The findings were contained in a 35-page letter from Blue Bell to the FDA and released under the Freedom of Information Act. A second letter covering the company's findings at its Alabama plant has not been made public. The agency also released test results.
Inspectors found listeria monocytogenes in the Alabama plant in early April, despite Blue Bell's previous comments that the plant there had not been linked to the outbreak. Of 137 swabs, one tested positive.
Last week, results from a private laboratory showed ice cream eaten by a man hospitalized in Florida contained listeria. It came from the Alabama plant. Florida officials insisted the man does not have listeriosis, but he was never tested specifically for the disease, his lawyer said. Public health officials do not consider it a listeriosis case without a positive lab test, said Dr. Brendan Jackson, an epidemiologist for the Centers for Disease Control.
The CDC closed its investigation into the outbreak Wednesday, having definitively linked 10 illnesses to Blue Bell and seeing no new confirmed cases since the recall. Neither the Florida case nor one reported by a former Houston man, who filed the first listeria lawsuit against Blue Bell, have been linked.
The FDA documents provide a window into the extraordinary measures Blue Bell is taking to make plants unfriendly for pathogens – like examining thousands of welds on processing equipment and smoothing down the seams that are too rough to clean easily.
And the documents hint about the future: There's no timetable for a return to production, but Brenham will be the last plant up and running. Distribution and flavors will be limited initially.
Because listeria is widespread in the environment, it is sometimes impossible to pinpoint the source of an outbreak. The focus then turns to corrective measures, and Blue Bell is introducing cleaning, testing and training policies that go far beyond FDA requirements, said Bill Marler, the attorney representing the Florida man, Brent McRae.
Blue Bell will reroute pipes to eliminate condensation dripping into ice cream, a problem discovered years ago by inspectors. It will swap out equipment that may harbor bacteria, change the way it stores containers, eliminate wooden pallets that can't be sanitized, require new sanitary clothing for employees and institute a bevy of finished-product and environmental testing designed to prove the food is safe before it leaves a plant.
That's a rarity in industry, said Mansour Samadpour of IEH Laboratories, who helps companies implement such programs and recover from outbreaks.
In years past, Blue Bell repeatedly found listeria on floors and pallets in Oklahoma but did not extend testing to food contact surfaces, and its failures were "no better or no worse than probably 90 percent of the rest of the companies," Samadpour said.
The new procedures remind Marler of measures enacted at Snoqualmie Ice Cream, a much smaller producer in his home state of Washington, which shut down amid a listeria outbreak and recall in December. It has since resumed production.
Blue Bell is doing "what they always should have been doing and likely wish they had been doing," Marler said. " ... If I had a dollar for every company that found religion after a self-imposed disaster, I could have retired years ago."
Blue Bell CEO Paul Kruse issued a statement Wednesday saying he wants the company's new efforts to demonstrate how serious it is about eradicating problems.
"We are committed to seeing this plan through and to working with the FDA each step of the way," he said.
Brenham will be last to resume production because upgrades there will take the longest, according to Kruse's letter to the FDA. It's unclear whether that means Texas will have to wait longer than other states for Blue Bell's return.
The 10 listeriosis cases have been connected to tainted ice cream in four states, and three Kansas hospital patients died after listeria complicated preexisting illnesses. Although the CDC closed its investigation, the agency said more cases could be identified because some consumers still have tainted ice cream, which they should discard. The FDA investigation remains open.
Some devotees have shrugged off the total recall, eating ice cream still in their freezers and gambling that they won't get sick. Others have tried to capitalize by selling their uneaten treats online.
Multistate Outbreak of Listeriosis Linked to Blue Bell Creameries Products (Final Update)
- Read the Advice to Consumers, Institutions, and Retailers>>(http://www.cdc.gov/listeria/outbreaks/ice-cream-03-15/advice-consumers.html)
- Read the Information for Health Professionals>>(http://www.cdc.gov/listeria/outbreaks/ice-cream-03-15/health-professionals.html)
- This outbreak investigation is over. Information gathered as part of the investigation indicated that various Blue Bell brand products were the source of this outbreak of listeriosis.
- Listeriosis is a life-threatening infection caused by eating food contaminated with the bacterium (germ) Listeria monocytogenes (Listeria). People at high risk for listeriosis include pregnant women and their newborns, adults 65 and older, and people with weakened immune systems.
- A total of 10 people with listeriosis related to this outbreak were reported from 4 states: Arizona (1), Kansas (5), Oklahoma (1), and Texas (3). All ill people were hospitalized. Three deaths were reported from Kansas (3).
- On April 20, 2015, Blue Bell Creameries voluntarily recalled all of its products currently on the market made at all of its facilities, including ice cream, frozen yogurt, sherbet, and frozen snacks.
- Consumers should not eat any recalled Blue Bell brand products, and institutions and retailers should not serve or sell them. This is especially important for people at higher risk for listeriosis. These products are frozen, so consumers, institutions, and retailers should check their freezers.
- On May 7, 2015, the U.S. Food and Drug Administration released the findings from recent inspections at the Blue Bell production facilities in Brenham, Texas