483
Allergan Sales, LLCAllergan Sales, LLC – FDA 483, Nov 7, 2025
Record Details
Allergan Sales, LLC (BLI) in Irvine, CA, was cited for significant deficiencies in its drug substance manufacturing processes, particularly concerning contamination control and environmental monitoring. The inspection revealed inadequate process design, insufficient microbial control strategies, and flawed risk assessments, indicating a lack of assurance in maintaining drug substance quality and preventing contamination.
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ID · 22954531-e534-441b-863f-bbedcbf15b17
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