483
Allergan Sales, LLCAllergan Sales, LLC – FDA 483, Oct 8, 2015
Record Details
An FDA inspection of Alcon Sales, LLC in Waco, TX, revealed significant deficiencies in their manufacturing processes for human drug products. The observations included inadequate stability programs, scientifically unsound laboratory controls, and failures in preventing microbiological contamination. Additionally, issues with personnel gowning and environmental monitoring in aseptic processing areas were noted, raising concerns about product quality and sterility.
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ID · e9b4bc9b-ce35-4ebf-8179-ff221959c3ee
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