FDA 483 - Sciarra Laboratories, Inc. - August 07, 2023

Sciarra Laboratories, Inc. in Hicksville, NY, was inspected by the FDA from July 24 to August 7, 2023, revealing significant deficiencies in their manufacturing and quality control operations. The firm failed to adhere to good manufacturing practices, including issues with equipment calibration, process validation, stability testing, and documentation. These findings indicate a serious lack of control over critical processes and quality unit oversight.