FDA 483 - Wanbang Biopharmaceuticals - September 08, 2023
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 76373352-f34d-4509-8eae-ddc2c3492cd4