FDA 483 - Chemdex Inc - July 15, 2025

An FDA inspection of Chemdex Inc. in Lenexa, KS, revealed a critical failure in the quality unit's oversight of cleaning and maintenance systems for equipment used in manufacturing sterile drug products. Specifically, cleaning validation studies did not address microbiological or endotoxin contamination, and processes for reviewing reactor inspections and addressing recommended maintenance were not established. These issues pose a risk to the sterility and quality of their drug products.