FDA warns Aspen Hills concerning Listeria
The U.S. Food and Drug Administration (FDA) has sent the owners of Aspen Hills, makers of ready-to-eat cookie dough, a warning letter on January 10 about environmental samples from their facility that tested positive for Listeria monocytogenes.
The U.S. Food and Drug Administration (FDA) has sent the owners of Aspen Hills, makers of ready-to-eat cookie dough, a warning letter on January 10 about environmental samples from their facility that tested positive for Listeria monocytogenes.
The agency inspected Aspen Hill’s Garner, Iowa facility from Sept. 27 through Oct. 6, 2016, and found that four environmental swabs were positive for L. monocytogenes. Additionally, FDA investigators observed violations of the Current Good Manufacturing Practice (CGMP) regulation for foods. Based on these findings the agency determined that Aspen Hills’ frozen cookie dough products commonly called pucks, pellets, and pails are adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
At the end of the letter, the FDA acknowledged that the company did take extensive corrective actions, including hiring a third-party laboratory and consultant group to conduct a comprehensive review of its operations and to make recommendations for changes in its policy and procedures. In addition, the company revised its Standard Operating Procedures in three areas: 1) environmental pathogen monitoring; 2) product sampling and testing; and 3) cleaning and sanitizing facilities. The FDA noted that it will ascertain the adequacy of the corrective actions during its next inspection of the company.