Product Liability

FDA Warns Cookie Dough Maker That Listeria Threats Persist

cookie dough FDA image 279x210 FDA Warns Cookie Dough Maker That Listeria Threats PersistThe Iowa-based food manufacturer whose cookie dough products spurred recalls for Blue Bell ice cream, Weight Watchers sundaes, Publix-brand ice cream, and a number of other products for potential Listeria contamination has received a notice from federal regulators warning that the actions the company took to clean up its operations may not have been adequate.

Aspen Hills Inc. of Garner, Iowa, produces cookie dough and a variety of other products, which it supplies to other food producers who use them as an ingredient in their own products.

Ice cream manufacturer Blue Bell Creameries was the first to detect a problem with Aspen Hills’ cookie dough. In September, routine testing of Blue Bell ice cream found Listeria in ice cream flavors that incorporated the cookie dough from Aspen Hills.

That recall subsequently triggered food-safety recalls from other food manufacturers as well as a U.S. Food and Drug Administration (FDA) investigation of Aspen Hills’ products and facilities from Sept. 27 to Oct. 6.

FDA inspectors found at least four pieces of equipment in the Garner, Iowa, production facility tested positive for Listeria monocytogenes, a highly resistant bacteria that can thrive in freezing temperatures.

Listeria monocytogenes bacteria are not a leading cause of food poisoning, but they are among the deadliest of foodborne pathogens, causing about 255 deaths in the United States every year.

The FDA also referenced equipment swabs the company itself collected, which tested positive for Listeria in 10 cases, as well as one product test.

The agency said that the frequency of the findings, taken after the company took corrective actions, “indicates that your firm is not taking aggressive action to identify harborage sites for L. monocytogenes, to deep clean your facility effectively, and to prevent finished product contamination.”

“The WGS (whole genome sequencing) phylogenetic analysis of these 15 isolates finds that they comprise a single strain of L. monocytogenes,” The FDA’s warning letter states. “Comparing this strain to the larger WGS database shows that it matches three other isolates: two isolates from finished ice cream products tested by a commercial laboratory, and one isolate from a cookie dough ingredient sample collected by the state of Texas in 2016.”

The FDA acknowledges that Aspen Hills “took extensive corrective actions” after it received the inspections report, including hiring a third-party consultant, revising pathogen monitoring and testing procedures, and cleaning and sanitizing facilities.

But the agency said the company’s retraining of employees did not make sense because the dates provided for the retraining occurred several days before the problem was detected.

“These trainings were just prior to the start of our inspection on Sept. 27, 2016, and therefore cannot be considered to constitute corrective actions to issues identified during the inspection.”

The FDA said that it would ascertain the adequacy of the company’s corrective actions during its next inspection.

Food Safety News
U.S. Food and Drug Administration