Aspen SA Sterile Operations (Pty) Ltd. – FDA 483, Jul 14, 2026

An FDA inspection of Aspen SA Sterile Operations (Pty) Ltd. in Port Elizabeth, South Africa, a sterile drug product manufacturer, revealed significant deficiencies. The firm failed to establish adequate laboratory controls, including method suitability and stability testing, and did not properly follow quality control unit procedures for filling lines. Additionally, issues were noted with equipment performance qualification, production process controls, and the thorough investigation of manufacturing discrepancies.