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The paper explains the FDA doesn't require a pre-approval inspection of plants that make OTC medicines, and the FDA conducted just 684 overseas inspections in 2022; it has some 4,000 foreign facilities to inspect, and about 1 in 5 are in India.
Source: https://www.newser.com/story/333510/eye-drops-recall-deaths-blindness-now-an-fda-inspection.html
While the increased length between pre-approval and loan submission did not dissuade borrowers in Q2, the same cannot be said for Q3, as conversions from borrowers using QuickQual declined from 58% in Q2 to 53% in Q3.