FDA 483 - Calyx Chemicals & Pharmaceuticals Limited - November 04, 2019

CALYX CHEMICALS AND PHARMACEUTICALS LTD. in Boisar, India, an API manufacturer, was inspected by the FDA from November 4-8, 2019. The inspection revealed significant deficiencies in the firm's quality unit, including failures related to stability data, validation protocol approvals, critical deviation investigations, and laboratory control records for sample management. These issues indicate a lack of robust quality oversight and data integrity for active pharmaceutical ingredients and intermediates.