FDA 483 - ImprimisRx CA, Inc., dba ImprimisRx - March 31, 2017

An FDA inspection conducted at ImprimisRx CA, Inc., a producer of sterile drugs, from March 27 to March 31, 2017, identified significant observations regarding compliance with current Good Manufacturing Practices (cGMP). The findings indicate critical deficiencies in aseptic processing, complaint handling, and quality unit authority. Specifically, the inspection noted inadequate control of aseptic processing environments. Issues included improper material staging that compromised ISO-5 zone integrity, equipment obstructing critical first-air flow, and insufficient air quality monitoring. Furthermore, smoke studies intended to evaluate airflow patterns were found to be deficient, not reflecting dynamic operational conditions, and stained HEPA filters were observed. The firm's complaint management system also exhibited shortcomings. An adverse event involving an intravenous Curcumin solution was not properly documented, and numerous other Quality Related Events (QREs), including adverse drug events (ADEs) and product quality complaints, lacked essential investigative details and required comprehensive follow-up. Additionally, employee training on the most recent complaint procedures was inadequate. Finally, the inspection revealed that the Quality Control Unit lacked the necessary independence and authority to thoroughly investigate errors and implement effective corrective actions. Review processes for complaints and QREs were found to be insufficient, with quality assurance oversight missing for some customer complaints. ImprimisRx is required to address these observations to ensure the safety, identity, strength, quality, and purity of its sterile drug products.