# FDA 483 - Nehal J. Lakhani, M.D. - November 17, 2023

Source: https://www.keypedia.com/records/483/nehal-j-lakhani-md/fc7a206e-38ec-467d-b45c-17396913cdbc

> FDA 483 for Nehal J. Lakhani, M.D. on November 17, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nehal J. Lakhani, M.D.
- Inspection Date: 2023-11-17
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The FDA inspected Nehal J. Lakhani, M.D., a clinical investigator in Grand Rapids, MI, from November 13-17, 2023. The inspection revealed a significant issue with informed consent documentation, where subjects or their representatives did not sign or date consent forms for various sample collections and testing. This indicates a serious deficiency in adhering to regulatory requirements for human subject protection in clinical research.

## Related Officers

- [investigator](https://www.keypedia.com/people/chelsea-w-lamm/d7a8dd67-dc26-4c8a-8e3c-aebc267cb775)

Company: https://www.keypedia.com/companies/nehal-j-lakhani-md/cf16a0d3-6626-4ddf-8a99-a13799a85870

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0