FDA 483 - Assurance Infusion - December 03, 2019

An FDA inspection of Nanobots Healthcare, LLC dba Assurance Infusion, a producer of sterile drug products, revealed significant deficiencies in their manufacturing processes. Observations included a lack of endotoxin and sterility testing for intrathecal products, inadequate aseptic processing controls, and unverified depyrogenation and calibration procedures. These issues indicate a serious risk to the sterility and quality of their drug products.