FDA 483 - Par Formulations Private Limited - March 26, 2024

Par Formulations Private Limited in Dhar, India, was inspected by the FDA from March 18-26, 2024. The inspection revealed significant deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. These issues included failures in aseptic filling operations, inadequate cleaning procedures, shortcomings in environmental and personnel monitoring, unvalidated equipment, and incomplete laboratory qualification.