FDA WARNING_LETTER - Randy J. Epstein, M.D./Chicago Cornea Consultants, Ltd. - October 26, 2022

The FDA issued a Warning Letter to Dr. Epstein following an inspection from September 19 to October 26, 2022, under the Bioresearch Monitoring Program. The inspection reviewed the conduct of clinical investigations, specifically Protocol PXL-330, involving riboflavin solutions and UVA light.

The letter identifies two primary violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 312:

1. **Failure to Submit an Investigational New Drug (IND) Application:** Dr. Epstein initiated and conducted a clinical investigation of an investigational drug (riboflavin 0.25% transepithelial solution and riboflavin 0.1% hypotonic solution in combination with UVA light) under Protocol PXL-330, enrolling 32 human subjects, without submitting and having an IND in effect. The FDA noted that IRB approval does not negate the IND requirement. While Dr. Epstein acknowledged this and stated a review of regulations, the corrective action plan was deemed inadequate as it lacked details on how to determine when an IND is required and specifics on proposed training. This raises concerns about subject safety, welfare, and data integrity.

2. **Failure to Maintain Adequate Investigational Drug Records:** As sponsor-investigator, Dr. Epstein failed to maintain adequate records showing the receipt, shipment, or other disposition of the investigational drugs for Protocol PXL-33