FDA 483 - Xttrium Laboratories, Inc. - December 03, 2024

Xitrium Laboratories, Inc. in Lake Villa, IL, an API manufacturer, was cited for significant deficiencies across multiple areas of its quality system. Observations included failures in drug substance stability testing, inadequate sampling plans for process validation, and insufficient cleaning validation. Additionally, poor deviation management and issues with equipment cleaning procedures and construction were noted, posing risks to API quality.