FDA 483 - Cliantha Research Limited - April 17, 2026

Cliantha Research Limited, a biopharmaceutics facility in Ahmedabad, India, was issued an FDA Form 483 following an inspection conducted from April 13 to April 17, 2026. The investigators identified several critical deficiencies concerning data integrity, laboratory management, and clinical ethics. Key violations included the failure to maintain original source documentation, as staff recorded sample transfer details on scrap paper rather than in official logbooks. The firm also could not account for missing sample volumes and reported inaccurate data regarding which samples were used during analysis. A significant breakdown in quality oversight was noted, where laboratory analysts performed and concluded investigations into testing errors without the required review or approval from the Quality Unit. Additionally, the clinical portion of the inspection revealed that the facility performed invasive medical procedures, such as mammograms and ultrasounds, on participants before obtaining study-specific informed consent. These observations were made under the regulatory framework of the Food, Drug, and Cosmetic Act. Cliantha Research is expected to respond to these findings by implementing corrective actions or providing justifications for the observed practices to ensure the reliability of their research data and the safety of study participants.