Thymoorgan Pharmazie Gmbh – FDA 483, Apr 25, 2023

Thymoorgan Pharmazie Gmbh, a sterile drug manufacturer in Goslar, Germany, received a Form 483 with three observations. The inspection revealed significant deficiencies in discrepancy investigations, environmental monitoring for aseptic processing, and adherence to and documentation of production procedures. These issues indicate a lack of control over critical manufacturing processes for sterile drug products.