FDA 483 - Xttrium Laboratories, Inc. - June 16, 2026
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Xttrium Laboratories, Inc. in Mount Prospect, IL, a manufacturer of drug substances and drug products, was cited for significant deficiencies across its manufacturing and quality control operations. The inspection revealed issues with equipment design, cleaning, and maintenance, leading to potential microbial contamination, as well as inadequate investigations into out-of-specification results and a failure to follow established quality control procedures. Additionally, the firm failed to properly manage laboratory reference standards and reagents.
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