# FDA 483 - Asim Roy, M.D. - March 14, 2025

Source: https://www.globalkeysolutions.net/records/483/asim-roy-md/ece364ef-adcc-4d95-8928-87d6523c102d

> FDA 483 for Asim Roy, M.D. on March 14, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Asim Roy, M.D.
- Inspection Date: 2025-03-14
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Ohio Sleep Medicine And Neuroscience Institute in Dublin, OH, identified issues with investigational drug disposition records. The firm failed to maintain adequate and organized investigational product accountability records, leading to confusion regarding dispensing dates, quantities, and subject use. This indicates a significant concern regarding data integrity and record-keeping practices for clinical trials.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/craig-t-rybus/246aad79-6370-42e2-af6e-c0079c1bcbc6)

Company: https://www.globalkeysolutions.net/companies/asim-roy-md/ae5d12f0-c992-4c07-808b-9eb64bfd9c00

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22