FDA 483 - Zen Chemicals Private Limited - March 28, 2023

Zen Chemicals Pvt. Ltd. in Dombivili, India, was cited for significant deficiencies in equipment cleaning and sanitation, data integrity, and quality system controls. The inspection revealed visibly dirty equipment, a lack of investigations into analytical data discrepancies, inadequate computer system access controls, and untrained cleaning personnel. These issues indicate a serious breakdown in maintaining a state of control for critical API intermediate manufacturing.