FDA 483 - Aware Environmental Pty Ltd - July 09, 2019

The FDA inspection of Scental Pacific Pty. Ltd. in Bayswater, Australia, revealed widespread deficiencies across its quality, production, packaging, labeling, facilities, equipment, and laboratory control systems. The firm failed to adhere to its own standard operating procedures, adequately qualify personnel and equipment, validate manufacturing processes and test methods, and maintain complete and accurate records for drug products shipped to the U.S. These systemic issues indicate a significant lack of control over critical aspects of drug manufacturing and quality assurance.