FDA 483 - New Vision Pharmaceuticals LLC - March 23, 2023

An FDA inspection of New Vision Pharmaceuticals LLC in Tamarac, FL, a sterile drug manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate procedures for preventing microbiological contamination, insufficient validation of aseptic processes, and a lack of established production and process controls for sterile drug products. Additionally, the firm failed to properly follow quality control unit responsibilities and maintain adequate equipment cleaning procedures.