Optum Infusion Services 308 LLC – FDA Warning Letter, Mar 18, 2022

The FDA inspected Optum Infusion Services 308 LLC in Chandler, AZ, from March 8-18, 2022, identifying serious deficiencies in sterile drug product production. The inspection revealed drug products were prepared, packed, or held under insanitary conditions, rendering them adulterated under FDCA Section 501(a)(2)(A).

Key violations included: 1. Failure to perform adequate product evaluation and corrective action after observing vermin in the production area, risking contamination of sterile products. 2. Failure to perform adequate product evaluation and corrective action after recovering microbial contamination within the ISO 5 aseptic processing area. 3. An operator placing gloved hands outside the ISO 5 area to retrieve supplies without sanitizing them before re-entry, a prohibited act under FDCA Section 301(k).

The FDA reviewed the firm's April 8, 2022, response to the Form FDA 483 but found several corrective actions inadequate due to insufficient information or supporting documentation. Specifically, details on pest control installations (insect light traps, air/vortex curtains) and implementation timelines were missing. The retrospective review of affected "compounds" lacked supporting evidence, and the firm's assessment of microbial contamination in the ISO 5 area was deemed insufficient, as any contamination is a serious concern requiring immediate, thorough impact assessment. Additionally, referenced training documentation was not provided.

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