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.
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