483
A&Z Pharmaceutical IncFDA 483 - A&Z Pharmaceutical Inc - September 26, 2025
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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.
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ID · 747a9a46-2274-4a1a-a1f2-f93fd5d149e2