FDA 483 - Velocity Pharma LLC - December 14, 2023

Velocity Pharma LLC, a warehouse and distributor in Farmingdale, NY, received a Form 483 with four observations following an FDA inspection from November 3 to December 14, 2023. The firm was cited for deficiencies in its quality control unit's responsibilities, inadequate storage conditions for drug products, incomplete distribution records, and an insufficient product recall system. These issues highlight a lack of robust controls to ensure drug product quality, integrity, and traceability.