483
Fougera Pharmaceuticals, Inc.FDA 483 - Fougera Pharmaceuticals, Inc. - March 26, 2026
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An FDA inspection of Fougera Pharmaceuticals, LLC. in Hicksville, NY, a non-sterile drug manufacturer, revealed a significant concern regarding equipment maintenance. The firm failed to adequately maintain equipment and utensils, specifically hoses used in manufacturing and filling operations, to prevent contamination. This deficiency could compromise the safety, identity, strength, quality, or purity of their drug products.
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ID · 3378ff57-f3ea-43e3-bacd-abd188d5a398