# FDA 483 - James Melvin Rajan, M.D. - October 26, 2023

Source: https://www.globalkeysolutions.net/records/483/james-melvin-rajan-md/a9d62076-e018-4fae-9483-ab52f26a07a0

> FDA 483 for James Melvin Rajan, M.D. on October 26, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: James Melvin Rajan, M.D.
- Inspection Date: 2023-10-26
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: James Melvin Rajan, M.D. in Canton, OH, a Principal Investigator, was cited for significant failures in maintaining study records during an FDA inspection. The inspection revealed a lack of informed consent documents and study source records for subjects who were consented, screened, treated, or transferred, including two subjects who reportedly died. These deficiencies indicate a serious breakdown in the integrity of clinical trial documentation.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/james-melvin-rajan-md/cdd2b99d-d61e-4a5d-8c93-c9dd4c7b8d4a

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