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FDA issued Form 483 with observations to Lupin's New Jersey facility following an inspection.
The U.S. Food and Drug Administration issued a Form 483 with three observations to Lupin’s New Jersey facility following an April 2026 inspection.
The company confirmed it will address the findings and reaffirmed its commitment to current Good Manufacturing Practices.
This follows a separate Form 483 issued in March 2026 for Lupin’s Indian plant.
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La FDA emitió el formulario 483 con observaciones a las instalaciones de Lupin en Nueva Jersey después de una inspección.