The FDA has sent the owners of Aspen Hills, Inc., makers of ready to eat cookie dough, a warning letter on January 10, 2017 about environmental samples from their facility that tested positive for Listeria monocytogenes. There is zero tolerance for that pathogenic bacteria in ready to eat products. That means that the cookie dough pucks, pellets, and pails are adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act.
Four positive environmental swabs were collected in the manufacturing areas. And between September 18 and 26, 2016, the firm’s environmental program found Listeria monocytogenes in ten environmental swabs and in one finished product lot of cookie dough, which was not distributed into commerce.
These findings indicate that the “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,” according to the letter. Whole genome sequencing (WGS) analysis was conducted on the four isolates obtained by the FDA and the eleven other isolates. The findings are that the isolates comprise a single strain of Listeria monocytogenes.
Once Listeria bacteria is established in a production area, it can be moved around by personnel and equipment and can be very difficult to eradicate. Facilities must identify the places where the bacteria harbor and take corrective action to destroy it.
The firm took extensive corrective actions after the findings, including hiring a third-party lab and consultant group. The owners also revised their Standard Operating Procedures. The firm also recalled all lots of RTE cookie dough produced last year between June 8 and September 30. This resulted in a slew of secondary recalls, mostly of ice cream products made with the cookie dough.
Violations of Current Good Manufacturing Practices at the facility included employees spraying floors while uncovered cookie dough was in the area. Residual flour, shortening, and liquid pasteurized egg were found on the floor of the production room, and employees and forklifts were passing through it. And an employee was observed spraying the floor and drain of the production room, which caused water to splash on equipment parts.
The employees also left pasteurized liquid egg product on a scale throughout the day. Rust was found on some equipment, and missing bolt holes were filled with debris.
