Updated: FDA slaps Optum Infusion with a warning letter over 'insanitary' production conditions
The FDA issued a warning letter to Optum Infusion Services last month citing a list of potential contamination concerns, including “vermin” found in a production area.
The letter, posted by the FDA on Tuesday, accuses Optum of producing sterile drug products “under insanitary conditions.” It follows a Form 483 filed back in March upon inspection of the company’s Chandler, AZ, site.
An investigator reported that Optum failed to “perform adequate product evaluation and take appropriate corrective action after vermin was observed in your production area,” and after “microbial contamination was recovered” in an aseptic processing area.
“An operator placed their gloved hands outside the ISO 5 area to retrieve supplies without sanitizing their gloved hands before re-entry into the ISO 5 hood,” the letter states.
While the FDA noted that some of Optum’s responses “appear adequate,” the company “did not include sufficient information or supporting documentation.” For example, Optum said it changed pest control providers, installed insect light traps, and would put up air curtains and plastic flap curtains on certain entryways — but the FDA noted that it’s “unclear when these corrective actions will be fully implemented.”
In addition, Optum said it held on-site training in response to the contamination accusations. However, the FDA said that the company didn’t provide an Aseptic Technique Evaluation Update, and recommends that management conduct “a comprehensive assessment of operations” on its aseptic processing in particular, with the help of a third-party consultant.
“FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems,” the letter reads.
“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,” Optum said in an email to Endpoints News.
This story has been updated to include comment from Optum.