FDA 483 - New Vision Pharmaceuticals LLC - October 29, 2021

The FDA inspection of New Vision Pharmaceuticals LLC in Tamarac, FL, revealed critical deficiencies in the firm's quality control unit and investigation processes. The Quality Unit consistently failed to provide adequate oversight, properly review investigations, adhere to its own procedures, and thoroughly investigate water system contamination by objectionable organisms like Burkholderia cepacia complex and Ralstonia insidiosa, which impacted numerous batches of OTC drug products, including those for children. These failures indicate a severe lack of control over manufacturing processes and product quality.