FDA 483 - Alphapharm Pty, Ltd. - June 28, 2024

An FDA inspection of Alphapharm Pty, Ltd. in Carole Park, Australia, a drug manufacturer, revealed significant deficiencies in equipment cleaning and maintenance procedures. Inspectors found that written procedures were inadequate, leading to residue on equipment marked as clean, and that deviations from production controls were not properly justified. These observations indicate a lapse in the firm's adherence to good manufacturing practices.