483
iuvo BioScience Operations, LLCFDA 483 - iuvo BioScience Operations, LLC - May 15, 2026
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Canyon Rush, LLC, a contract laboratory in Rush, NY, was cited for significant deficiencies in laboratory controls and record-keeping during an FDA inspection. Observations included a pervasive lack of contemporaneous documentation and data integrity issues, failures to follow internal investigation procedures, and inadequate incubation conditions for microbiological testing. These issues indicate a systemic breakdown in quality control and data reliability.
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