FDA 483 - Cliantha Research Limited - April 17, 2026

An FDA inspection of Cliantha Research Limited's Biopharmaceutics Analytical and Clinical Facility in Ahmedabad, India, revealed significant deficiencies across multiple areas. The firm failed to consistently investigate internal standard variations, maintain proper source documentation, and account for missing sample volumes. Additionally, the quality unit did not perform adequate laboratory investigations, and legally effective informed consent was not obtained from subjects.