FDA 483 - Suzhou Union Biopharm Co., Ltd. - May 26, 2023

An FDA inspection of Suzhou Union Biopharma Co. Ltd. in Suzhou, China, a drug substance and drug product manufacturer, revealed significant deficiencies. Observations included inadequate procedures to prevent microbiological contamination during sterile drug product manufacturing, deficient quality unit oversight, and inadequate written procedures for record-keeping and quality reviews. These issues indicate a lack of control over critical manufacturing processes and quality systems.