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

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.