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.
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: