FDA says Listeria came from outside supplier, not Blue Bell

Federal inspections of the cookie dough maker involved in Blue Bell's latest listeria-related recall confirmed that the bacteria stemmed from the outside supplier, effectively settling a dispute between the two companies regarding the origin of the contamination.

The Food and Drug Administration slapped the supplier, Iowa-based Aspen Hills, with a warning letter last month that detailed the company's failures to properly safeguard its products from contamination. The department found Listeria monocytogenes, a disease-causing strain of the bacteria, in four areas of the Aspen Hills plant, and the company itself identified the pathogen in 10 areas as well as one finished batch of cookie dough that was not distributed to customers.

The FDA also discovered widespread sanitation problems in the company's manufacturing methods, which it noted were "inadequate to effectively control pathogens." The agency declined Wednesday to comment on the situation, citing an ongoing investigation.

Wednesday night, Aspen Hills owners Thomas and Nancy Lundeen announced that in light of the findings they have decided to leave their business, perhaps by selling it. The company ceased all production at the end of December.

"We are committed to addressing any questions raised by the FDA so that the agency can be assured that our commitment to the safety and wholesomeness of our products will not waver even as we exit the market," Aspen Hills spokesman Jon Austin said in an email.

In its letter to the company, the FDA noted that the strain of listeria discovered in the plant matched one discovered in two batches of Blue Bell cookie dough flavors in September. The ice cream maker held those products from distribution and traced the contaminant to unopened packages of an Aspen Hills cookie dough ingredient.

Aspen Hills initially questioned that finding, insisting that none of its products had tested positive for listeria. But it voluntarily issued its own recall and reviewed its manufacturing practices in response.

Both companies expanded their recalls in October after Aspen Hills admitted that it might have lapsed on its food safety standards, potentially exposing some of its products to the bacteria. Blue Bell pulled from the market every product it had ever produced with the cookie dough ingredient and immediately suspended its relationship with the supplier.

Brenham-based Blue Bell declined to comment Wednesday on the FDA's findings. A spokesperson said in an email that the company hasn't yet found another cookie dough supplier.

The series of recalls proved especially untimely for Blue Bell, an iconic brand now working to rebuild production capacity and market share after a listeria-related crisis crippled the company in April 2015. Blue Bell ultimately recalled all of its products and halted production as a result of contamination linked to 10 listeria cases, including three deaths.

Since then, Blue Bell has adopted stringent testing measures to ensure the safety of its products. In the wake of the latest recall, it pointed to its discovery of the bacteria as evidence of the effectiveness of its test-and-hold procedures.

The FDA's findings confirmed that Aspen Hills had indeed lapsed on its safety practices, which the company has since worked to strengthen and enforce. It ultimately pulled 19 products from the market, prompting other ice cream producers including Blue Bunny and Publix to recall certain flavors.

During inspections at the Aspen Hills plant in September and October, federal regulators observed "serious violations" of safety in the company's manufacturing methods. During one cleaning session, employees sprayed the floors near uncovered White Chocolate Macademia cookie dough, splashing water from the floor onto some equipment.

Workers also failed to clean their boots and aprons after visiting a dumpster with trash from the production room floor, which was at one point covered with flour, shortening and "liquid pasteurized egg ingredient." Some employees trekked through and left footprints in the mess, while others failed to clean spilled egg product off a scale used to measure it.

The company's equipment, too, posed potential hazards. Inspectors found rust on a cookie dough cutter and mixers used for all of the company's products, and some of the mixers had debris in holes left by missing bolts.

The FDA noted in the letter that Aspen Hills has already taken extensive measures to improve its facility, but it gave the company about three weeks to respond with a more detailed correction plan. Aspen Hills said Wednesday it has explained to the agency the procedural changes it put in place in response to the findings, even though the future of the company remains uncertain.