483
Nehal J. Lakhani, M.D.FDA 483 - Nehal J. Lakhani, M.D. - November 17, 2023
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Record Details
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.
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ID · fc7a206e-38ec-467d-b45c-17396913cdbc