483
ALI Pharmaceutical Manufacturing LLCALI Pharmaceutical Manufacturing LLC – FDA 483, May 3, 2024
Record Details
An FDA inspection of ALI Pharmaceutical Manufacturing, LLC in Omaha, NE, a human drug substance manufacturer, revealed significant deficiencies in laboratory controls. The firm was cited for invalidating out-of-specification (OOS) results without scientific justification and for inadequate investigations into critical deviations and batch failures, including a repeat observation. These issues indicate a lack of robust quality control and investigation processes.
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ID · 102d7b3d-d9ab-490f-9da6-b177fa57520e
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