January 17, 2020

FDA Sends Warning Letter to Friendly’s Ice Cream

The FDA has sent a warning letter to Friendly’s, maker of ready-to-eat ice cream products, syrups, and fudge, about the presence of Listeria monocytogenes in their processing facility. There is zero tolerance for Listeria monocytogenes in ready-to-eat foods.

FDA Sends Warning Letter to Friendly's Ice Cream

The FDA inspected the company’s facility from July 278, 2019 to August 20, 2019. Inspectors found “serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR part 117),” according to the letter. Environmental samples revealed Listeria monocytogenes in the facility. That strain matches bacteria found during the FDA’s 2017 inspection. And the letter states,”The presence of the same strain of Listeria monocytogenes over multiple years indicates that there has been a resident pathogen in your facility since 2017.”

The company’s hazard analysis did not identify a “known or reasonably foreseeable hazard that requires preventive control.” The food is exposed to the environment at several steps during the manufacturing process where food could be contaminated with environmental pathogens. Friendly’s did discard food manufactured during the time that environmental swabs revealed contamination.

The letter states, “These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent Listeria monocytogenes in your facility. Once Listeria monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product.

A review of the firm’s environmental monitoring program showed that they repeatedly found Listeria species (not necessarily Listeria monocytogenes) throughout the processing facility. For example, from January 2018 through December 2018, 20.9% of all swabs taken were positive for Listeria species.

The company, according to the letter, did not take reasonable measures and precautions to make sure that all people working in direct contact with food conformed to hygienic practices while on duty. An employee in charge of mixing did not wash and sanitize his hands or glove after touching scoop handles. This is a repeat observation from the 2017 inspection.

In addition, the plant is not constructed in such a manner that drip or condensate from fixtures, ducts, or pipes does not contaminate food, food contact surfaces, or food packaging materials. Condensate was observed dripping over the filler heads while containers were being filled with ice cream. This is another repeat deficiency from the 2017 inspection. Green pails designated for finished products that were used to hold overflow ice cream during production were placed directly below pipes where condensate dripped into them.

The inspections also found that the company was not cleaning utensils and food contact surfaces as often as necessary to protect against contamination. Cake molds had food debris on them after they went through the dishwasher, and employees continued to use those molds. And non-contact food surfaces were not cleaning as frequently as necessary.

Friendly’s has responded, stating that they have taken a number of corrective actions which include intensified cleaning and sanitizing, and conducting a root cause analysis. The FDA will verify the implementation and adequacy of these corrections during the next inspection.

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