FDA 483 - Xttrium Laboratories, Inc. - December 06, 2024

An FDA inspection conducted from December 3-6, 2024, at Xttrium Laboratories, Inc., an API manufacturer, revealed significant deviations from regulatory expectations at its Lake Villa, IL facility. The inspection identified six primary observations, primarily concerning the manufacturing of Chlorhexidine Gluconate (CHG). Key issues included a deficient stability testing program, with the firm failing to conduct accelerated stability studies on all validation batches and lacking forced degradation studies to ensure analytical methods were stability-indicating. An expiration date was assigned to CHG despite observed accelerated stability failures, without sufficient scientific justification or risk assessment.

Furthermore, sampling plans for process validation lacked scientific rationale, failing to ensure adequate batch representation. Cleaning validation was found inadequate, as the company failed to assess worst-case products when using shared manufacturing equipment, and cleaning procedures lacked sufficient detail. A significant deviation involving out-of-specification yields for CHG validation batches was closed without proper investigation, corrective actions, or correction of the underlying master batch record error. Lastly, observations noted issues with equipment cleanliness and construction, including discolored gaskets and unaddressed hinges, and the absence of a maintenance plan for critical components.

These findings indicate a need for comprehensive corrective actions across quality systems related to stability, process validation, cleaning validation, deviation management, and equipment control to ensure compliance with good manufacturing practices and safeguard drug substance quality.