FDA EIR - Lifepoint Research, LLP - January 14, 2022

An FDA inspection was conducted at Lifepoint Research, LLP in Wakad, Pune, India, from January 10 to January 14, 2022. The inspection was a high-priority bioequivalence assessment of a clinical study for Vigabatrin tablets (ANDA 210042). This review was conducted under the regulatory framework of 21 CFR Part 320 and Compliance Program 7348.003, focusing on Clinical In-Vivo BA/BE studies. The inspection revealed significant concerns, resulting in the issuance of an FDA Form 483 for failure to conduct foreign clinical studies in accordance with good clinical practices. A main violation was the site's inability to perform required vision assessments, including visual field interpretation, because the contracted ophthalmologist lacked the necessary perimetry device on-site, leading to unscheduled subject visits and unavailability of the device for verification. Another issue involved a pre-screened subject who was not randomized but inappropriately signed a Post-trial Access Informed Consent Form and received investigational medication. Management, specifically Dr. Sunil Chaudhary, Director of the Clinical Research Department, committed to correcting these issues and submitting a written response to the FDA within fifteen business days.