FDA 483 - Aspen SA Sterile Operations (Pty) Ltd. - December 04, 2018

Aspen SVP Pty Ltd. in Port Elizabeth, South Africa, was cited for significant deficiencies in its manufacturing processes for sterile drug products. The inspection revealed widespread issues with aseptic techniques, quality control unit oversight, laboratory controls, and facility maintenance, indicating a systemic failure to prevent contamination and ensure product quality.