FDA 483 - Rentschler Biopharma SE - March 07, 2023

Rentschler Biopharma SE, a drug substance intermediate manufacturer in Laupheim, Germany, was cited for significant deficiencies during an FDA inspection. Observations included inadequate microbial contamination prevention, improper environmental monitoring practices, failures in quality unit responsibilities, and unqualified cell bank transport systems. These issues indicate a lack of robust quality control and risk management in critical manufacturing processes.