FDA 483 - A&Z Pharmaceutical Inc - September 26, 2025

A&Z Pharmaceutical Inc, a manufacturer in Hauppauge, NY, was cited for deficiencies in its quality control unit during an FDA inspection. The firm's quality unit failed to establish a robust analytical data integrity evaluation program, lacking specific responsibilities and procedures for verifying electronic data and conducting audit trail reviews. This indicates a significant concern regarding the validity of test results and data controls.