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.
From August 19-26th the FDA inspected a ready-to-eat (RTE) candies and snack food manufacturing facility located in Arizona, called Cerreta Candy Company. The inspection 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 adulterated. There were no labeling violations on this one, but the cGMP violations were numerous.
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From July 9th– 17th the FDA inspected a fresh cut produce manufacturing facility located in Texas. The inspection resulted in the FDA issuing of a Warning Letter to the company. There were numerous severe violations. Although there were not labeling based issues, the violations in regards to cGMPs and PCs were numerous.
May 7-8, 2019 and June 7, 2019 FDA inspected Tugusto Foods, down in Puerto Rico. We like this Warning Letter because we can see some label violations, but we would be remiss to not at least give the highlights of the serious cGMP and related food safety violations observed. If anyone is looking for either a clear example of how not to operate a food facility, or even perhaps a comprehensive guide to attracting and collecting pests – this read is hard to beat.
From June 24- July 3, 2019 the FDA inspected U.S. Dairy Unlimited, LLC., a ready-to-eat (RTE) cheese manufacturing facility, located in Miami, FL. The inspection resulted in the FDA issuing of a Warning Letter to the company. Although there were not labeling based issues at U.S. Dairy Unlimited, the serious cGMP and food safety observations seemed unlimited.
In recent news the company Keurig Dr. Pepper, now the parent company of Dr. Pepper, has been found by the 9th circuit appeals court that it did not intentionally mislead customers by using the term “diet” to describe its soda.
The decision was filed December 30th by Judge Jay Bybee that California resident Shana Becerra was unable to show that a consumer would associate drinking diet soda with health benefits. Becerra had sought legal action claiming that the company misled consumers with the word “diet” when numerous studies show aspartame, the artificial sweetener used, can cause weight gain and has zero benefits to weight loss. The judge however ruled that there is a fine line in what is truly deceptive and companies are not at fault if a consumer unreasonably interprets the term, as long as the company itself makes no claims that are intentionally misleading.
From July 29, 2019 to August 20, 2019, FDA inspected Dean Foods-owned Friendly’s Manufacturing and Retail in Wilbraham, MA. At this facility, the make ready-to-eat foods including ice cream products, syrups, and fudge. If you currently need a kick start your New Year’s resolution of healthier eating, look no further. This Warning Letter could have you scared of cheat days for months to come.
A few of the observation highlights:
From July 8-11, 2019, the FDA performed an inspection at California Cereal Products’ dry cereal manufacturing facility in Macon, GA. The inspection resulted in the Agency issuing a Warning Letter to the company. Although there were no label compliance issues to highlight from this one, the serious cGMP violations were almost TNTC (too numerous to count).
Four major observations of violations made it into the Warning Letter:
There has been significant buzz in the industry around cannabidiol (CBD), however, the US Food and Drug Administration (FDA) has sent a firm reminder on the compound’s non-legal status. This past month the agency sent 15 warning letters to companies illegally selling products containing CBD. The companies were cited for marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to foods.