Rocket Pharmaceuticals, Inc. – FDA 483, Jan 25, 2024

During an inspection conducted from January 9 to January 25, 2024, at Rocket Pharmaceuticals, Inc.'s corporate headquarters in Cranbury, NJ, the U.S. Food and Drug Administration (FDA) observed deficiencies related to the conduct of a clinical study. The findings, documented in a Form FDA 483, indicate issues with ensuring proper clinical investigation oversight, as per regulatory expectations. Specifically, the company failed to secure complete investigator statements (Form FDA-1572) for all participating investigators and research facilities involved in their clinical study protocol (b) (4). This included instances where unlisted investigators conducted study visits at unlisted facilities. Furthermore, Rocket Pharmaceuticals did not ensure adequate monitoring of the study to uphold adherence to the investigational plan. Monitors reportedly failed to properly document and report protocol deviations, such as investigational product infusions occurring outside defined timelines for multiple subjects, and significant delays (over a year) in identifying numerous missed reconsenting deviations. The inspection also noted that certain local study visits were conducted prior to the protocol version that allowed for such arrangements. Rocket Pharmaceuticals is required to respond to these observations by addressing the identified conditions and practices to demonstrate compliance with relevant FDA regulations concerning clinical trials.