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

An FDA inspection conducted from March 27-31, 2017, at ImprimisRx CA, Inc., a producer of sterile drugs in Irvine, CA, identified significant compliance issues, resulting in a Form 483. Three key observations were detailed. Firstly, deficiencies were noted in the aseptic processing areas, critical for maintaining sterility. Issues included a cart left exposing an ISO-5 zone to an ISO-7 area, large equipment blocking first-air passage in laminar airflow hoods, inadequate smoke studies failing to simulate dynamic conditions, and discolored HEPA filters. Corrective actions for these airflow issues had not been implemented. Secondly, the firm's complaint recordkeeping was found lacking. Investigations into adverse events, such as one involving an intravenous Curcumin solution, were not adequately documented. Many of the 69 Quality Related Events (QREs) in 2016 and early 2017 lacked critical information, and adverse drug events (ADEs) required more thorough investigation and corrective actions. Additionally, employees were not trained on the most current complaint procedures. Finally, the Quality Control Unit lacked sufficient authority to fully investigate errors. The absence of a separate, independent Quality Control Unit hindered comprehensive investigations and the implementation of effective corrective actions, as evidenced by customer complaints not being reviewed by Quality Assurance (QA) as per established procedures. ImprimisRx is required to address these observations promptly to ensure compliance with good manufacturing practices.