FDA 483 - Muhammad Y. Sheikh, M.D. - February 11, 2022

An FDA inspection of Muhammad Y. Sheikh, M.D. in Fresno, CA, revealed that a clinical investigation was not conducted in accordance with the signed statement of investigator and investigational plan. The primary issue involved the randomization of multiple ineligible subjects into Protocol MGL-3196-14. These subjects failed to meet various exclusion or inclusion criteria, indicating significant deviations in study conduct and screening procedures.