logo Aspen Hills Inc.Thomas and Nancy Lundeen may never look at Groundhog’s Day the same again. They’ve got until then to respond to an FDA warning letter about Listeria in their cookie dough and production plant — give or take a day depending on how long it took an overnight service to deliver the letter.

The Lundeens are co-owners of Aspen Hills Inc., a company in Garner, IA, that produces a variety of food products, including cookie dough for other food producers’ products and for fund-raising projects by groups such as schools and churches.

Federal officials have been working with the company since this past fall to resolve food safety problems at the Iowa plant, but as of the Jan. 10 warning letter, “serious violations” remain. The Lundeens have 15 working days to respond to the warning letter.

A spokesman for Aspen Hills said earlier this week that the company is “working on its response” to the Food and Drug Administration. He did not provide information about the operational status of the cookie dough production lines or other activities at the Iowa facility.

The background
Aspen Hills recall ripple illustrationIn September 2016 tests by one of Aspen Hills’ customers — Blue Bell Creameries — showed Listeria monocytogenes and spurred a ripple of recalls of several brands of ice cream and other products containing Aspen Hills cookie dough. The finding by Blue Bell also sparked an investigation by the Food and Drug Administration, which revealed a number of problems at the Iowa cream production facility.

Federal officials informed Aspen Hills’ owners about the problems during the inspection, which lasted from Sept. 27 to Oct. 6, 2016. The FDA also issued the company a “Form-483, Inspectional Observations” report that included suggestions of how to resolve the food safety problems at the facility.

The Lundeens responded, but failed to meet requirements of federal law, according to the FDA’s Jan. 10 warning letter.

“We acknowledge your firm’s responses dated Nov. 1, 2016, and Dec. 19, 2016, to the FDA-483, which include a description of corrective actions taken by your firm. We address the adequacy of specific corrective actions below,” the warning letter states.

The problems
FDAWarningcolor_406x250At least four pieces of equipment in the production facility tested positive for Listeria monocytogenes, all of them in the production room and either in direct contact with dough or adjacent to it. The FDA has redacted specific names of equipment and processes from the public version of the warning letter to protect “confidential company information.”

In addition to the positive results from equipment swabs collected Sept. 28 by FDA, the agency’s warning letter also references 10 Listeria monocytogenes positive results the company itself got from equipment swabs it collected from Sept. 16-28. There was also a positive Listeria monocytogenes result from one sample of finished product.

“The frequency of these environmental findings in conjunction with your finished product finding 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 warning letter states.

“The (whole genome sequencing) WGS phylogenetic analysis of these 15 isolates finds that they comprise a single strain of L. monocytogenes. 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 response
FDA WarningThe FDA did acknowledge that Aspen Hills “took extensive corrective actions” after receiving the agency’s inspection report. The hiring of a third-party consultant and revisions of procedures for pathogen monitoring and testing, as well as cleaning and sanitizing were noted in the warning letter. However, the FDA left little wiggle room for the company.

“We will ascertain the adequacy of your corrective action during our next inspection,” was repeated throughout the warning letter, which also cited problems with the Aspen Hills response regarding employee training.

The Aspen Hills owners submitted revised procedures, but they did not include information on implementation dates, making it impossible for FDA officials to know if the procedures were in place before or after the Listeria problems were discovered.

The company owners also attempted to rely on retraining of employees as part of its response, but the dates didn’t add up.

“… the training records supplied with your response show employees were trained on topics such as “Sanitation” (on) 9/13/16 and “Highlighted Proper Sanitation, High APC counts and Importance of properly cleaned facility” on 9/15/16,” according to the warning letter.

“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.”

Editor’s note: For additional background on Aspen Hills recalled cookie dough and related recalls, please see:

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