FDA Warns U.S. Dairy Unlimited

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.

Exterior image of the facility inspected

Here is a small tasting of the FDA’s observations:

  • Hazard analysis was not conducted at the facility. Issues around this include not identifying biological hazards, not evaluating for environmental pathogens, such as Listeria monocytogenes and salmonella. The plant also did not identify physical hazard risks such as metal.
  • The plant also did not identify allergens which is a foreseeable hazard and requires a preventative control.
  • The company failed to identify and implement preventive controls providing assurances that the food processed at the facility would not be adulterated. These included process controls, allergen controls, sanitation controls, supply-chain controls, and a recall plan.
  • The plant was not constructed in a manner that condensation would not contaminate food, food-contact surfaces, or food-packaging materials. Condensation was found dripping onto stainless steel molds and other vessels used to store the ready-to-eat cheese.
  • It was also observed that the food was at high risk of becoming adulterated. Specifically observed during the audit an employee was found banging the molds of cheese against the handle of a metal cart, during which the soft cheese came in direct contact with the handle.  The handle was observed to be non-smooth cleanable surface which could adulterate the product.  There was also observations of pipes leaking and food debris buildup in food contact surfaces among numerous other findings which the FDA outlined in the letter.

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.