FDA 483 - Chemdex Inc - February 27, 2023

An FDA inspection of Chemdex Inc., an API manufacturer in Lenexa, KS, revealed significant deficiencies across three observations. The firm failed to establish adequate preventative maintenance schedules and cleaning procedures for equipment used in manufacturing Iron Hydrogenated Dextran Bulk Solution 10%. Additionally, the inspection found a lack of proper monitoring and control for microbial counts and endotoxins in water used in final manufacturing steps for a non-sterile API intended for a sterile drug product.