FDA 483 - Jindal Drugs Private Limited - March 22, 2024

Jindal Drugs Private Limited in Navi Mumbai, India, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies in facility cleaning and maintenance, environmental controls, water system monitoring, and quality control procedures for API manufacturing. Issues included unvalidated cleaning methods, inadequate storage conditions, microbial contamination in the water system, and insufficient supplier evaluation, impacting products distributed to the U.S.