FDA 483 - Rocket Pharmaceuticals, Inc. - January 25, 2024
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An FDA inspection of Rocket Pharmaceuticals, Inc. in Cranbury, NJ, revealed deficiencies in their clinical study conduct. The firm failed to obtain complete investigator statements (Form FDA-1572) before allowing investigators to participate and permitted study visits at unlisted facilities. Additionally, the inspection found a failure to ensure proper study monitoring, leading to undocumented protocol deviations and non-adherence to the investigational plan regarding investigational product administration and local study visits.
ID · 53f7e6ee-2105-45c0-bf05-6f122fba4654