The agency cited a presence of vermin at drug compounding site in Arizona.
The U.S. Food and Drug Administration issued a warning letter to Optum Infusion Services over unsanitary conditions at one of its locations where it compounds drugs.
The FDA inspected an Optum Infusion facility in Chandler, Ariz., in March 2022 and found "serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk," the FDA wrote in the letter posted publicly on Tuesday.
Optum is owned by Minnetonka-based UnitedHealth Group, which ranks among the five largest public companies in the U.S. UnitedHealth Group CEO Andrew Witty was previously CEO of Eden Prairie-based Optum.
Because of the deficiencies found in the inspection, the drug products produced did not meet federal regulations, the FDA said.
"You did not perform adequate product evaluation and take appropriate corrective action after vermin was observed in your production area," the letter said. "Vermin are a source of microbial contamination."
The FDA sent the warning letter to Optum in mid-December.
In the letter, the FDA recommended several steps for Optum to address the concerns.
"FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials and systems," the letter said. "A third party consultant with relevant sterile drug processing expertise should assist you in conducting this comprehensive evaluation."
Infusion services are part of Optum Rx, one of Optum's three business units. Optum Rx also includes pharmacy networks.
Infusion therapies are drugs that are administered through needles or catheters, most commonly IVs. Optum's unit, according to its website, offers the therapies both at patients' homes and infusion facilities.
In a statement to the Star Tribune, Optum Rx said: "We are committed to providing safe, convenient and affordable access to medications for our patients. We have instituted enhancements to our current processes to address the FDA observations."
Information and technology firm Wolters Kluwer said Optum is "one of the leading home infusion companies in the country with coverage coast to coast."
From 2019 to 2021, Optum Infusion grew from 40 to 52 branches, Netherlands-based Wolters Kluwer reported.
"Because of the rapid growth, there was lack of standardization with respect to cleanroom certifications, policies or competencies," the firm wrote in a 2021 case study.
Optum tapped Wolters Kluwers to address those challenges.
Last week, UnitedHealth reported $324.2 billion in revenue for 2022, with a profit of $20.1 billion.
Reporter: Burl Gilyard is the Star Tribune's medtech reporter.