FDA 483 - Wanbang Biopharmaceuticals - September 08, 2023

Wanbang Biopharmaceuticals in Xuzhou, China, was inspected as a manufacturer of drug products, revealing significant deficiencies. The firm failed to establish and follow adequate procedures to prevent microbiological contamination during aseptic processing, including issues with RABS cleaning and technician sanitization. Additionally, the inspection found a failure to thoroughly investigate an Out-of-Specification assay discrepancy and noted deficient laboratory records lacking complete calculations for various tests.