FDA 483 - Aspen SA Sterile Operations (Pty) Ltd. - September 17, 2024

An inspection of Aspen SA Sterile Operations (Pty) Ltd. revealed critical deficiencies in aseptic processing, quality control, and data integrity for sterile drug products. The firm failed to establish and follow procedures to prevent microbiological contamination, adequately validate aseptic processes, and thoroughly investigate numerous stability failures, out-of-specification results, and customer complaints. These issues indicate a severe lack of control over manufacturing processes and product quality, posing significant risks to product sterility and efficacy.