FDA 483 - Isorx Corp - September 18, 2019

Isorx, Corp. in Richmond, CA, was inspected by the FDA from September 9-18, 2019, revealing significant deficiencies in aseptic processing controls. The firm failed to properly disinfect materials and cleaning agents, and did not effectively use sporicidal agents. Additionally, the inspection found that batch production and control records for sterile drug products were incomplete and lacked essential information.