The US Food and Drug Administration (FDA) is ramping up its monitoring of firms in areas of the world considered high risk for manufacturing products susceptible to diethylene glycol (DEG) and ethylene glycol (EG) substitution, or those using high-risk excipients vulnerable to contamination.
The move follows deaths attributed to drugs tainted with these chemicals, Matthew Dionne, an FDA compliance officer, said at the Pharmaceutical Quality Symposium sponsored by the Small Business and Industry Assistance (SBIA) program on 1 November 2023. He pointed out that DEG and EG contaminated products have not affected the US supply chain…
