# FDA 483 - Rapa Therapeutics LLC - June 02, 2025

Source: https://www.keypedia.com/records/483/rapa-therapeutics-llc/c265fc9e-cd06-4b6c-b56b-51e0b0973351

> FDA 483 for Rapa Therapeutics LLC on June 02, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rapa Therapeutics LLC
- Inspection Date: 2025-06-02
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: Rapa Therapeutics LLC, a sponsor in Rockville, MD, was cited for significant deficiencies in the monitoring of a clinical study during an FDA inspection from May 27 to June 2, 2025. The firm failed to implement proper monitoring plans and SOPs, perform source data verification, identify root causes for protocol deviations, and ensure timely submission of data safety monitoring board reports to the Institutional Review Board. These issues indicate a lack of adequate oversight in conducting the study according to protocol and Good Clinical Practice guidelines.

## Related Officers

- [Consumer Safety Officer/BIMO Investigator](https://www.keypedia.com/people/david-l-chon/227b9c21-14c4-442b-bdc3-ad167567fd92)

Company: https://www.keypedia.com/companies/rapa-therapeutics-llc/d6777b24-b9c7-47cd-b93c-9d2703ce8592

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa