FDA 483 - Velocity Pharma LLC - October 23, 2020

Velocity Pharma LLC, a pharmaceutical drug repacker/relabeler in Farmingdale, NY, was cited for significant deficiencies in its quality control systems. The inspection revealed a lack of written procedures for production and process controls, specifically the absence of filling process validation studies for its drug products. Additionally, the firm failed to establish and follow validated written procedures for the cleaning and maintenance of its equipment.