FDA 483 - MAC-Chem Products (India) Ltd. - April 06, 2018

MAC-Chem Products (India) Ltd. in Thane, Maharashtra, was inspected by the FDA from April 2-6, 2018, resulting in two observations. The inspection revealed deficiencies in the firm's production system, specifically regarding the lack of process validation for API manufacturing changes and insufficient stability data for increased batch sizes. Additionally, the materials system was cited for inadequate monitoring of the USP water system, failing to fully evaluate test samples for chemical attributes.