FDA WARNING_LETTER - U.S. Dairy Unlimited, LLC - July 03, 2019

The FDA inspected U.S. Dairy Unlimited, LLC, a ready-to-eat (RTE) cheese manufacturer, from June 24 to July 3, 2019, finding serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The inspection resulted in an FDA Form 483, and no response has been received.

The FDA determined that the cheese products are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Violations include:

* **Hazard Analysis and Risk-Based Preventive Controls (Subpart C):** * Failure to conduct a hazard analysis for any products (21 CFR § 117.130(a)), specifically not identifying biological hazards (pathogen survival/growth due to inadequate time/temperature control during pasteurization and storage), environmental pathogens (e.g., *Listeria monocytogenes*, *Salmonella*) for RTE food exposed to the environment post-lethal treatment, physical hazards (metal from utility knives, cutting wires, staples), and undeclared allergens (milk) due to incorrect labeling. * Failure to identify and implement preventive controls (21 CFR § 117.135(a)(1)). * Failure to prepare or implement