Delsam Pharma LLC – FDA 483, Mar 24, 2023

Delsam Pharma LLC, an own-label distributor in Bronx, NY, was inspected and cited for significant deficiencies across its quality system. Observations include the absence of a quality control unit, improper storage conditions for sterile drug products, lack of complaint handling procedures, inadequate distribution records for recalls, and failure to conduct annual product reviews. These issues indicate a severe lack of fundamental controls for ensuring drug product quality and safety.