FDA 483 - Melanie M Hoppers, MD - December 15, 2023

The FDA conducted an inspection of Melanie M Hoppers, MD, a clinical investigator, from December 6 to December 15, 2022. The inspection resulted in a Form FDA 483, identifying significant issues related to the conduct of a clinical study, particularly a study titled (b) (4).The primary observation noted that the investigation was not carried out in accordance with the signed investigator statement and the approved investigational plan. Specifically, Dr. Hoppers, as the Principal Investigator, failed to adequately personally conduct or supervise the study. This deficiency led to several critical violations, including the improper enrollment of six out of eighteen study subjects who did not meet the essential protocol inclusion criterion of having a specific (b) (4) test result.Furthermore, the inspection revealed widespread alteration of source records for all eighteen subjects. Laboratory reports were found to have modified dates and were incorrectly used to represent analytical results for different subjects. The study coordinator reportedly performed these alterations, which severely compromised the integrity and reliability of the clinical trial data.Issued under the Federal Food, Drug, and Cosmetic Act, the FDA 483 requires Melanie M Hoppers, MD, to address these observations. The firm must provide a response detailing corrective actions implemented or planned to ensure future compliance with regulatory standards for clinical investigations.