FDA 483 - Aeropres Corp - June 27, 2023

Aeropres Corp in Manhattan, IL, was inspected by the FDA, revealing significant deficiencies in its quality unit, laboratory data review, and computerized system controls. The inspection found that the firm failed to investigate non-conforming results, lacked proper review of GC calibration data, and did not ensure the authenticity and integrity of electronic data, potentially impacting the quality of aerosol propellants. These issues indicate a lack of adherence to Current Good Manufacturing Practices.