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Dr. Maria A. Carballosa was cited for failures in conducting an in vivo bioavailability-bioequivalence clinical study at Power MD Clinical Research Institute in Hialeah, Florida, identified during an FDA Bioresearch Monitoring Program inspection in March 2025. The primary violation involved failure to retain required clinical investigation records for the mandatory two-year period following drug marketing application approval or discontinuation of the investigation, as mandated under 21 CFR 312.62(c). Additionally, Dr. Carballosa failed to maintain adequate case histories documenting drug disposition (including dates, quantities, and subject usage) and complete observational records as required under 21 CFR 312 for clinical investigator conduct.