FDA 483 - ImprimisRx NJ - August 05, 2022

ImprimisRx NJ, a producer of sterile and non-sterile drug products, was cited for significant deficiencies in aseptic processing, environmental control, and cleaning practices during an FDA inspection. Observations included visibly dirty ISO 5 areas, inadequate personnel gowning and material disinfection, poor cleanroom maintenance, and issues with air quality and unidirectional airflow. The firm also released drug products with inconsistent potency due to variable capsule filling.