Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistCatalent Indiana, LLC, a drug manufacturing facility in Bloomington, received a warning letter for significant Current Good Manufacturing Practice (CGMP) violations in finished pharmaceutical production. The FDA's June-July 2025 inspection found that the company failed to conduct adequate investigations into drug product failures and discrepancies, with investigations frequently lacking supporting data, incomplete scope, poor documentation, and inadequate corrective action verification—including cases where failures involving extrinsic contaminants like mammalian hair were not properly assessed for product impact. These manufacturing control failures rendered the company's drug products adulterated under federal law.