FDA 483 - Carsgen Therapeutics Corporation - December 06, 2023

Carsgen Therapeutics Corporation received a Form 483 with 15 observations, indicating significant deficiencies across its quality control, aseptic processing, facility maintenance, production controls, and data integrity systems. The firm failed to establish written procedures for critical operations, maintain adequate environmental controls, thoroughly investigate discrepancies, and ensure proper training, leading to potential product contamination and mix-ups for its clinical manufacturing operations. These issues highlight a systemic lack of robust quality management and control over its drug product manufacturing processes.