FDA issues Warning Letter : Cell Gene Therapy manufacturer

In November 2023, the US FDA issued a Warning Letter to CARsgen Therapeutics Corporation, a CAR T cell manufacturer, due to Good Manufacturing Practice (GMP) violations found during an inspection. The FDA reported serious deficiencies, including unclean manufacturing facilities. An incident on July 14, 2023, involved a box of food with fly pupae found in a room containing technical HVAC equipment, which remained until July 31, 2023. Fly larvae were later detected in ten monitoring samples from cleanrooms.

Moreover, the company lacked adequate particle monitoring in aseptic areas, crucial for detecting contamination risks. The FDA emphasized that monitoring non-viable particles and viable microorganisms is essential for patient safety. Additionally, the cleaning procedures for manufacturing equipment had not been validated, raising concerns about contamination. The manufacturer claimed a new cleaning program was effective, but the FDA noted that supporting data was not provided. Finally, a 100% visual inspection of the finished product was not conducted, which compromises quality assurance.