FDA WARNING_LETTER - Tyrone L. McCall, M.D./Cornea Associates of Texas - September 19, 2022

An FDA inspection conducted between September 12 and 19, 2022, reviewed Cornea Associates of Texas's role as a sponsor and Dr. McCall's role as an authorized representative and clinical investigator. The inspection, part of the Bioresearch Monitoring Program, found that Cornea Associates did not adhere to applicable statutory requirements in the FD&C Act and 21 CFR Part 312 governing clinical investigations and human subject protection. Specifically, Cornea Associates failed to submit an Investigational New Drug (IND) application for a clinical investigation of investigational drugs, a combination product, under Protocol (b)(4), involving 69 human subjects. This was a violation of 21 CFR 312.20(a), 312.20(b), and 312.40(a), as the product did not qualify for an IND exemption under 21 CFR 312.2. The firm's September 27, 2022, response to the Form FDA 483, which stated a misunderstanding of IND exemption criteria, immediate cessation of enrollment, and subsequent IND submission, was deemed inadequate. FDA noted the response lacked sufficient details on how the firm would determine IND requirements, ensure compliance with 21 CFR Part 312, guarantee pre-IND meetings, or provide staff training. This failure raises significant concerns about subject safety, welfare, and data integrity. Cornea Associates must notify FDA within 15 business days of actions taken to prevent future violations, or face potential regulatory action.