FDA 483 - Kekule Pharma Limited - March 15, 2024

An FDA inspection of Kekule Pharma Limited in Sangareddy, Telangana, India, from March 11-15, 2024, revealed a significant lapse in quality control procedures. The firm failed to document, explain, and investigate deviations from established procedures, specifically regarding temperature excursions in a control sample storage room. This indicates a serious concern with the firm's quality management system and its ability to ensure product quality and integrity.