483
ALI Pharmaceutical Manufacturing LLCALI Pharmaceutical Manufacturing LLC – FDA 483, Dec 1, 2017
Record Details
An FDA inspection of American Laboratories Inc. in Omaha, NE, revealed significant deficiencies in their active pharmaceutical ingredient operations. Observations included discarding analytical data to mask process variation, inadequate procedures for handling returned opened products, and inaccuracies in complaint investigations. The inspection also noted issues with the firm's deviation and discrepancy investigation process, potentially leading to undocumented deviations.
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ID · 2cd46e70-9b2a-475f-92d5-516cc6921f0a
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