HIKMA PHARMACEUTICALS USA INC. – FDA 483, Jul 13, 2026

An FDA inspection of HIKMA PHARMACEUTICALS USA INC. in Berkeley Heights, NJ, revealed a significant deficiency in their post-marketing surveillance system. The firm lacked adequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse drug experiences for combination products, specifically regarding 30-day malfunction reportability. This included a failure to document malfunction-reportability assessments for several cases involving their Fluticasone Propionate and Salmeterol Inhalation Powder product.