Following the deadly Escherichia coli outbreak linked to McDonald’s onions supplied by Taylor Farms, through a Freedom of Information Act (FOIA) request, CBS News released U.S. Food and Drug Administration (FDA) reports documenting some questionable food safety and hygiene observations at the implicated Taylor Farms facility.

The FDA reports uploaded by CBS News (a link to the original documents can be followed here) covered inspections conducted at Taylor Farms’ Colorado Springs facility between October 28 and November 12, 2024. Many parts of the Form 483 were redacted by FDA.

What is a Form 483?

Known as a Form 483, the document is issued to communicate "objectionable" conditions observed during inspection, which may lead to the "adulteration" of a product or a product being rendered "injurious to health," according to FDA.

According to Jennifer McEntire, Ph.D., Founder of consultancy Food Safety Strategy and former CEO of the International Fresh Produce Association, not all Form 483s are the same. "Official Action Indicated" (OAI) indicate more grave concerns than "Voluntary Action Indicated" (VAI) forms. The Form 483 issued to Taylor Farms unveiled by CBS News was a VAI. According to Dr. McEntire, per the FDA Data Dashboard, the Taylor Farms Colorado Springs Facility has been inspected regularly, approximately every three years; the recent Form 483 is the first VAI document (the rest being "No Action Indicated"). Although the findings on a Form 483 "must be addressed," she explained, they may not be indicative of the problems leading to an outbreak. The release of the FOIA-requested form may come from increased scrutiny following the facility's implication as the onion supplier in the McDonald’s outbreak.

Observations in the Form 483

The Form 483 had three major observations: 1) "you [Taylor Farms] did not implement your sanitation preventive control, monitoring, corrective action and verification," 2) "you did not have sanitation control monitoring, corrective action and verification record," and 3) "you did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food." Subpoints reported in FDA’s Form 483 to Taylor Farms included, but were not limited to:

• Equipment with apparent biofilm and food debris were found, even after post-operation cleans. Following cleans, food contact areas that should have been marked “fail” were marked as “pass.”
• Improper employee personal hygiene was seen, such as personnel handling ready-to-eat (RTE) produce and food contact surfaces not using any handwashing sinks. Employees sometimes used hand sanitizer over gloved hands only.
• Food contact equipment was not dried after sanitization, and improper concentrations or mixtures of sanitizer were used.

In a statement to CBS News, Taylor Farms stated that the company “is confident in our best-in-class food safety processes, and in turn, the quality and safety of our products. As is common following an inspection, FDA issued observations of conditions that could be improved at one of our facilities." Taylor Farms said it immediately took steps to address the issues listed in FDA’s Form 483.

In October 2024, illnesses caused by E. coli infection began surfacing in people who consumed McDonald’s Quarter Pounder sandwiches. FDA determined fresh, slivered onions served on the sandwiches, which were supplied by Taylor Farms’ facility in Colorado Springs, Colorado, to be the source of the outbreak. By the close of the outbreak investigation on December 3, a total of 104 people infected with the outbreak strain of E. coli O157:H7 were reported from 14 states, resulting in 34 known hospitalizations, four cases of hemolytic uremic syndrome (HUS), and one death (not HUS-related).

Update, January 21, 2025: The article has been edited to include greater context about the nature of a Form 483 and provide clarity in the language.