The FDA sent a warning letter to Optum Infusion Services Dec. 13 after the agency said it found "serious deficiencies" in safety practices at a Chandler, Ariz., facility where it produces compounded medications.
In the letter published Jan. 17, the agency wrote that an FDA investigator inspected the facility 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."
Specifically, the investigator found that Optum did not take appropriate corrective action when vermin were found in the production area, therefore introducing the potential for product contamination. The company also did not take appropriate corrective action "after microbial contamination was recovered within the ISO 5 aseptic processing area," according to the letter.
An operator had also placed their gloved hands outside the aseptic area to retrieve supplies but did not sanitize their gloved hands before reaching back in.
The FDA wrote that Optum's responses to the findings and some corrective actions "appear adequate," but it could not confirm adequacy because the company did not provide enough information or documentation.
In the FDA's first example, it wrote that Optum "changed pest control providers, installed insect light traps, and … will be installing air curtains on exterior doors and plastic flap curtains inside of the warehouse door." The agency wrote that it is unclear where the actions will be taken "in relation to the classified areas" or when they will occur.
Optum also said it was updating staff training processes, and said a review of noted issues found "no product or patient impact," but the FDA said the response lacked evidence to support it.
"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.
Optum Infusion facilities increased from 40 to 52 locations from 2019 to 2021, the Star Tribune reported Jan. 18.
"We are committed to providing safe, convenient and affordable access to medications for our patients," an Optum Rx spokesperson told the newspaper. "We have instituted enhancements to our current processes to address the FDA observations."
Read the full letter here.