The FDA is struggling to resume factory inspections worldwide, resulting in a backlog of overdue inspections that pose serious contamination risks, particularly in critical drug supplies.
Generic drugmakers face pressure to reduce costs, which may lead to compromised quality. The lack of inspections means potential problems might only be detected when it's too late.
Last year's outbreak linked to contaminated eyedrops from an Indian factory highlights the dangers of insufficient oversight, where tainted drugs can result in severe, even fatal, consequences.
A significant portion of U.S. drug supply manufacturers have not been inspected since before the pandemic, representing about 42% of registered plants, increasing risks to public health.
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