FDA 483 - Lawrence W. Johnson, M.D. - October 13, 2023

The FDA issued a Form 483 to Louisiana Research Center Llc. in Shreveport, LA, following an inspection that revealed significant deficiencies in the conduct of a clinical investigation. The firm failed to properly supervise the study, ensure subjects met eligibility criteria, and obtain informed consent from four out of eleven randomized subjects. These findings indicate serious non-compliance with regulatory requirements for human subject protection and clinical trial conduct.