FDA 483 - Aeropres Corporation - June 22, 2023

An FDA inspection of Aeropres Corporation, a manufacturer of aerosol propellants for drug products in Morris, IL, revealed significant deficiencies in their quality control and data integrity practices. Observations included a failure of the quality unit to document and investigate non-conforming results, a lack of quality review for laboratory data, and inadequate controls to ensure the authenticity and integrity of computerized systems and raw data. These issues indicate a lack of adherence to Current Good Manufacturing Practice.