US FDA Adds Hand Sanitizer Import Alert Category After COVID-19 Production Surge Turned Deadly
Action responds to methanol contamination in hand sanitizers manufactured in Mexico and marketed in the US under numerous brands that followed a loosening standards for the products to drive a swift increase in production and meet surging demand during the coronavirus pandemic.
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The 31 March cut-off date brings to a comparatively low-profile end a well-chronicled saga of FDA acting to increase OTC hand sanitizer production as consumer demand soared in response to COVID-19.
"Fewer people are manufacturing the products ... That seems to be a sort of a natural reaction to I think the decreased consumer demand," says Donald Ashley, compliance chief in FDA’s drug center.
Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over the past year – and may play key role post-pandemic.