Loading…
Randy J. Epstein, M.D./Chicago Cornea Consultants, Ltd. failed to adhere to federal regulations governing the conduct of clinical investigations under 21 CFR Part 312 while conducting two drug trials: Protocol PXL-330 evaluating riboflavin solutions combined with ultraviolet-A light for corneal cross-linking, and a second investigational drug study (details redacted). The inspection, conducted September-October 2022 as part of FDA's Bioresearch Monitoring Program, identified objectionable conditions related to human subject protection, research conduct, and compliance with investigational drug requirements. Despite the company's November 2022 response to the FDA's inspection findings, the agency determined that the violations were not adequately remedied.