FDA EIR - D.Venu Gopal Reddy - October 24, 2024

An FDA surveillance inspection was conducted at Axis Clinicals Ltd. in Hyderabad, India, specifically focusing on Dr. D.Venu Gopal Reddy as a clinical investigator. The inspection occurred from October 21 to October 24, 2024. This was Dr. Reddy's initial FDA inspection as a clinical investigator. The inspection was carried out under the regulatory framework of the Abbreviated New Drug Application (ANDA) pre-approval data validation and compliance program 7348.003 for In Vivo Bioequivalence - Clinical studies, aimed at evaluating a clinical study supporting an ANDA.

The scope of the inspection encompassed various aspects of clinical study conduct, including informed consent processes, ethics committee approvals, adherence to study protocols and eligibility criteria, investigational product management, adverse event reporting, and the handling of pharmacokinetic samples. Clinical study data verification was performed by comparing original source data against reports submitted to the Agency.

Crucially, the inspection concluded with no findings of non-compliance. No FDA Form 483, which details objectionable conditions, was issued, nor were any verbal observations conveyed to the firm. Consequently, the inspection received a "No Action Indicated (NAI)" classification, signifying that no further regulatory actions are required from the company based on this particular inspection.