Richard W. Foltin, Ph.D. Warning Letter Details

Summary

Richard W. Foltin, Ph.D. failed to submit required Investigational New Drug Applications (INDs) before conducting clinical investigations with investigational drugs, in violation of 21 CFR 312.20 and 312.40(a). The FDA inspection conducted in February-March 2023 identified that Dr. Foltin, acting as a drug sponsor, initiated multiple clinical protocols without proper IND authorization or qualifying for an exemption under 21 CFR 312.2, thereby failing to comply with statutory requirements under the Federal Food, Drug, and Cosmetic Act and applicable regulations governing clinical investigations and human subject protection. The violations were documented in an Establishment Inspection Report and Form FDA 483, to which Dr. Foltin responded on March 23, 2023, but corrective actions were deemed insufficient.