From May 22nd – June 4th the FDA inspected a ready-to-eat (RTE) ice cream manufacturing facility in Wisconsin, called Sassy Cow Creamery. The inspection was initiated in response to a recall of mislabeled ice cream and resulted in the FDA issuing of a Warning Letter to the company. During inspection FDA investigators found numerous severe violations which led them to determine that the products manufactured at the facility were held in unsanitary conditions and were deemed adulterated.
So now let’s dive into the violations listed in the Warning Letter released.
- They failed to implement an effective food safety plan which provides the assurances that hazards including undeclared allergens will be minimized or prevented
- Specifically, the allergen controls within the facility were inadequate in protecting the finished food from becoming misbranded. For example, the firm packaged Bourbon Honey Pecan Ice Cream into containers that were labeled “Gluten Free Cookies N Cream”. This packaging error caused a Class I Recall for the undeclared tree nut allergen. A misstep in production with the packaging, not only initiated an FDA inspection but also potentially jeopardized a consumer with a tree nut allergy.
- Sanitation controls were as well significantly under par regarding the established SOPs for the equipment. There were several procedures written, however there was a lack of verification activity documented to show proper preventative controls. For example, Listeria spp. was determined to be apart of the facilities environmental program but when swabbing had been conducted and an out-of-specification result was found, there was no corrective actions in place and/or documented.
- The frequency in which environmental monitoring was done was also found to be sub-par with an absence of monitoring verification activities for the months of August 2018, October 2018, January 2019, and March 2019. When companies don’t document activities especially when it comes to verifying safety the FDA will take note. If it isn’t documented, it never happened doesn’t matter how in line a company may be, due to the federal law and regulations the documentation of such activities is as equally important as doing the task itself.
To read the letter in full, click HERE.
If anything in the letter sounds familiar from your facility, or you would just like to be better prepared for your own FDA inspection when the time comes, let us know. In addition to label compliance reviews, we do facility audits and consulting on following cGMPs. Contact us today to discuss your needs and get a free quote.