# FDA 483 - Devalingam Mahalingam, M.D., Ph.D. - October 18, 2024

Source: https://www.globalkeysolutions.net/records/483/devalingam-mahalingam-md-phd/4ce1169e-341a-4f08-a2f4-c77c9be80c69

> FDA 483 for Devalingam Mahalingam, M.D., Ph.D. on October 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Devalingam Mahalingam, M.D., Ph.D.
- Inspection Date: 2024-10-18
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Devalingam Mahalingam, M.D., Ph.D. in Chicago, IL, a clinical investigator, revealed significant deficiencies in clinical trial conduct. Observations included a failure to properly investigate a serious adverse event involving an investigational drug overdose that led to a subject's death. Additionally, the inspection found multiple instances where short form informed consent documents lacked required witness signatures for non-English speaking subjects.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/yuanyuan-li/2043568b-a6ac-4f49-8018-c2c8edda8ac5)
- [issuing_officer](https://www.globalkeysolutions.net/people/vidhi-j-jani/2e8e2811-bcb6-49dc-8c36-bd3ed73874cf)
- [Muhammad Naiman](https://www.globalkeysolutions.net/people/muhammad-naiman/5c62c1ce-b6d3-424a-9738-f91b395bad46)

Company: https://www.globalkeysolutions.net/companies/devalingam-mahalingam-md-phd/0626a329-c4bc-4ba6-aa8b-1c6821d6529a

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669