# FDA 483 - Rocket Pharmaceuticals, Inc. - January 25, 2024

Source: https://www.keypedia.com/records/483/rocket-pharmaceuticals-inc/53f7e6ee-2105-45c0-bf05-6f122fba4654

> FDA 483 for Rocket Pharmaceuticals, Inc. on January 25, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rocket Pharmaceuticals, Inc.
- Inspection Date: 2024-01-25
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

Company: https://www.keypedia.com/companies/rocket-pharmaceuticals-inc/7268c8fe-86f7-418b-af02-d18f00aa54dc

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248