483
Xttrium Laboratories, Inc.Xttrium Laboratories, Inc. – FDA 483, Dec 3, 2024
Record Details
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.
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ID · f27a0c35-886c-4e51-a07d-155b8f0623b6
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